Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

NCT01500551 | Completed Phase 2 Results DMC

• 3 other identifiers: A3921145JIA2023-509651-14-00
• Study Type: interventional
• Target: 302
• Locations: 19 countries
• Sites: 104

Brief Summary

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Arthritis; Pediatric; Long-term; JIA; CP-690,550; tofacitinib; Xeljanz

Outcome Measures

Primary Outcomes (26)

• Number of Participants With Laboratory Test Abnormalities

  Parameters: Hematology (hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, prothrombin international normalized ratio, erythrocyte sedimentation rate), clinical chemistry (bilirubin, direct/indirect bilirubin, aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high and low density lipoprotein cholesterol, Friedewald estimation, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, C reactive protein), urinalysis (specific gravity, potential of hydrogen (pH), glucose/ protein/ hemoglobin/ erythrocytes/ leukocytes, ketones, leukocyte esterase, hyaline casts, bacteria). Number of participants with at least 1 laboratory abnormality are reported.

  During study treatment (maximum up to 118 months)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that met one or more of the following criteria: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. An TEAE was any AE that occurred following the start of study treatment in this study or increased in severity following the start of study treatment in this study. AE included both SAEs and all non-SAEs.

  From start of the study intervention up to 28 days after last dose of the study intervention or until study completion or withdrawal, whichever is longer (maximum up to 118 months from start of study intervention)

• Absolute Values of Body Weight at Baseline

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  At Baseline

• Absolute Value of Body Weight at Month 12 and Its Change From Baseline at Month 12

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 12

• Absolute Value of Body Weight at Month 24 and Its Change From Baseline at Month 24

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 24

• Absolute Value of Body Weight at Month 36 and Its Change From Baseline at Month 36

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 36

• Absolute Value of Body Weight at Month 48 and Its Change From Baseline at Month 48

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 48

• Absolute Value of Body Weight at Month 60 and Its Change From Baseline at Month 60

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 60

• Absolute Value of Body Weight at Month 72 and Its Change From Baseline at Month 72

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 72

• Absolute Value of Body Weight at Month 84 and Its Change From Baseline at Month 84

  Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 84

• Absolute Value of Height at Baseline

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  At Baseline

• Absolute Value of Height at Month 12 and Its Change From Baseline at Month 12

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 12

• Absolute Value of Height at Month 24 and Its Change From Baseline at Month 24

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 24

• Absolute Value of Height at Month 36 and Its Change From Baseline at Month 36

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 36

• Absolute Value of Height at Month 48 and Its Change From Baseline at Month 48

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 48

• Absolute Value of Height at Month 60 and Its Change From Baseline at Month 60

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 60

• Absolute Value of Height at Month 72 and Its Change From Baseline at Month 72

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 72

• Absolute Value of Height at Month 84 and Its Change From Baseline at Month 84

  Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

  Baseline, Month 84

• Number of Participants According to Tanner Stage at Baseline

  Pubertal development was measured using Tanner stage, by age group (2 to \<6 years, 6 to \<12 years, and 12 years or older) for males and females separately. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (fully developed breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes continue to enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size).

  At Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap)

• Number of Participants With Shift in Tanner Stage From Baseline to Month 12

  Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 12. Only rows with non-zero values were reported in this outcome measure.

  Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 12

• Number of Participants With Shift in Tanner Stage From Baseline to Month 24

  Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 24. Only rows with non-zero values were reported in this outcome measure.

  Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 24

• Number of Participants With Shift in Tanner Stage From Baseline to Month 36

  Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 36. Only rows with non-zero values were reported in this outcome measure.

  Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 36

• Number of Participants With Shift in Tanner Stage From Baseline to Month 48

  Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 48. Only rows with non-zero values were reported in this outcome measure.

  Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 48

• Number of Participants With Shift in Tanner Stage From Baseline to Month 60

  Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 60. Only rows with non-zero values were reported in this outcome measure.

  Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 60

• Number of Participants With Shift in Tanner Stage From Baseline to Month 72

  Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 72. Only rows with non-zero values were reported in this outcome measure.

  Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 72

• Number of Participants With Shift in Tanner Stage From Baseline to Month 84

  Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 84. Only rows with non-zero values were reported in this outcome measure.

  Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 84

Secondary Outcomes (113)

• Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Systemic Juvenile Idiopathic Arthritis (sJIA) 1 Analysis Set

  Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

• Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set

  Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

• Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set

  Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78

• Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Enthesitis Related Arthritis (ERA) Analysis Set

  Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

• Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Psoriatic Arthritis (PsA) Analysis Set

  Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36

Study Arms (1)

Tofacitinib

EXPERIMENTAL

All patients will be in tofacitinib treatment group.

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165) 5 mg BID Dose Level: Body Weight (Dose in tablet \[mg BID\] or solution \[ml BID\]) 5 - \< 7 kg (2 mg or 2 ml) 7 - \< 10 kg (2.5 mg or 2.5 ml) 10 - \<15 kg (3 mg or 3 ml) 15 - \<25 kg (3.5 mg or 3.5 ml) 25 - \<40 kg (4 mg or 4 ml) \>=40 kg (5 mg or 5 ml) Oral solution (1 mg/mL concentration) will be used for subjects weighing \<40 kg. Oral tablets (5 mg) will be used for subjects weighing \>=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution. Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing.

Also known as: CP 690,550, Xeljanz

Tofacitinib

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
• The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
• Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
• Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.

You may not qualify if:

• persistent oligoarthritis, and undifferentiated JIA.
• Infections:
• Chronic infections.
• Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
• Any treated infections within 2 weeks of baseline visit.
• A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
• History of infected joint prosthesis with prosthesis still in situ.
• History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (104)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Loma Linda University Children'S Hospital

Loma Linda, California, 92354, United States

Location

Loma Linda University Clinical Trials Center

Loma Linda, California, 92354, United States

Location

Loma Linda University Eye Institute

Loma Linda, California, 92354, United States

Location

Loma Linda University General Pediatric Clinic - Meridian

Loma Linda, California, 92354, United States

Location

Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)

Loma Linda, California, 92408, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)

San Bernardino, California, 92408, United States

Location

Rady Children's Hospital Center for Pediatric Clinical Research

San Diego, California, 92123, United States

Location

Rady Children's Hospital Rheumatology Clinic

San Diego, California, 92123, United States

Location

Rady Children's Hospital San Diego- Education and Office Building

San Diego, California, 92123, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Rady Children's Research Pharmacy

San Diego, California, 92123, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

IDS Pharmacy

Washington D.C., District of Columbia, 20010, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Center for Advanced Pediatrics

Atlanta, Georgia, 30329, United States

Location

AU Medical Center

Augusta, Georgia, 30912, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Tufts Medical Center - Floating Hospital for Children

Boston, Massachusetts, 02111, United States

Location

Explorer Clinic, University of Minnesota Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cohen Children's Medical Center of New York

Lake Success, New York, 11042, United States

Location

Columbia University Medical Center-Herbert Irving Pavillion

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Pediatric Research

Charlotte, North Carolina, 20207, United States

Location

Levine Children's Specialty Center

Charlotte, North Carolina, 28203, United States

Location

Atrium Health- Investigational Drug Services

Charlotte, North Carolina, 28207, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Randall Children's Hospital at Legacy Emanuel

Portland, Oregon, 97227, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Dell Children's Medical Group, Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Texas Children's Hospital- Clinical Care Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital- Clinical Research Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital- Investigational Pharmacy

Houston, Texas, 77030, United States

Location

Texas Children's Hospital- Main Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital/Baylor College of Medicine- Feigin Center

Houston, Texas, 77030, United States

Location

Intermountain - Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Instituto CAICI SRL

Rosario, Santa Fe Province, S2000PBJ, Argentina

Location

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Hospital Britanico de Buenos Aires

CABA, C1280AEB, Argentina

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

The Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven - Gasthuisberg

Leuven, 3000, Belgium

Location

SER - Serviços Especializados em Reumatologia

Salvador, Estado de Bahia, 40150-150, Brazil

Location

CMIP - Centro Mineiro de Pesquisa Ltda

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Hospital Pequeno Príncipe Clinical Research Office

Curitiba, Paraná, 80250-060, Brazil

Location

Faculdade de Medicina da UNESP

Botucatu, São Paulo, 18618-686, Brazil

Location

Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG)

Rio de Janeiro, 21941-912, Brazil

Location

SPDM - Associacao Paulista para o Desenvolvimento da Medicina

São Paulo, 04037-002, Brazil

Location

Instituto da Crianca do Hospital das Clinicas da FMUSP

São Paulo, 05409-011, Brazil

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

McGill University Health Center, Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215003, China

Location

The Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310057, China

Location

Beijing Children's Hospital, Capital Medical University/Rheumatology Department

Beijing, 100045, China

Location

PRI - Pediatric Rheumatology Research Institute GmbH

Bad Bramstedt, 24576, Germany

Location

Hamburger Zentrum fur Kinder und Jugendrheumatologie

Hamburg, 22081, Germany

Location

Asklepios Klinik Sankt Augustin GmbH

Sankt Augustin, 53757, Germany

Location

St. Josef-Stift Sendenhorst

Sendenhorst, 48324, Germany

Location

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 395002, India

Location

Institute of Child Health

Kolkata, West Bengal, 700017, India

Location

Institute of Post Graduate Medical Education and Research & SSKM Hospital

Kolkata, West Bengal, 700020, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Rambam Health Care Campus

Haifa, 31096 01, Israel

Location

Meir Medical Center - Pediatric Clinic

Kfar Saba, 4428164, Israel

Location

Chaim Sheba M.C Tel hashomer

Ramat Gan, 52621, Israel

Location

Clínica de Investigacion en Reumatologia y Obesidad, S.C.

Guadalajara, Jalisco, 44650, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

Centro de Alta Especialidad de Reumatología e Investigación del Potosí, S.C.

San Luis de Potosí, 78213, Mexico

Location

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, 78290, Mexico

Location

Unidad de Investigaciones Reumatologicas A.C.

San Luis Potosí City, 78290, Mexico

Location

Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego

Bydgoszcz, 85-667, Poland

Location

Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie

Krakow, 31-503, Poland

Location

Klinika Kardiologii i Reumatologii Dzieciecej

Lodz, 91-738, Poland

Location

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warsaw, 02-637, Poland

Location

FSBEI HE BSMU MoH RF

Ufa, Bashkortostan Republic, 450008, Russia

Location

Clinic of FSBEI HE BSMU MoH RF

Ufa, Bashkortostan Republic, 450083, Russia

Location

Federal State Budgetary Scientific Institution

Moscow, 115522, Russia

Location

FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University)

Moscow, 119435, Russia

Location

FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University),

Moscow, 119991, Russia

Location

FSAI "NMRCCH" of MOH Russia

Moscow, 119991, Russia

Location

FSBEI HE "St. Petersburg State Pediatric Medical University" of the Ministry of Healthcare

Saint Petersburg, 194100, Russia

Location

State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5"

Tolyatti, 445039, Russia

Location

Narodny ustav reumatickych chorob

Piešťany, 921 12, Slovakia

Location

Panorama Medical Centre

Panorama, CAPE TOWN, 7500, South Africa

Location

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, 4301, South Africa

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, 46026, Spain

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Umraniye Training and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

Location

Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu

Kadikoy / Istanbul, 34722, Turkey (Türkiye)

Location

Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.

Dnipro, 49006, Ukraine

Location

Ivano-Frankivsk Regional Children's Clinical Hospital

Ivano-Frankivsk, 76014, Ukraine

Location

Communal Non-profit Enterprise

Vinnytsia, 21000, Ukraine

Location

Birmingham Woman's and Children's NHS Foundation Trust

Birmingham, WEST Midlands, B4 6NH, United Kingdom

Location

Related Publications (2)

• Brunner HI, Akikusa JD, Al-Abadi E, Bohnsack JF, Boteanu AL, Chedeville G, Cuttica R, De La Pena W, Jung L, Kasapcopur O, Kobusinska K, Schulert GS, Neiva C, Rivas-Chacon R, Rizo Rodriguez JC, Vazquez-Del Mercado M, Wagner-Weiner L, Weiss JE, Wouters C, Posner H, Wouters A, Chang C, White C, Kanik K, Liu S, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study. Ann Rheum Dis. 2024 Oct 21;83(11):1561-1571. doi: 10.1136/ard-2023-225094.

  PMID: 38849152 DERIVED

• Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31.

  PMID: 38298058 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: March 18, 2013
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (7); IN (4); CA (3); PL (4); AU (2); BE (2); CN (3); ZA (2); RU (8); AR (3); GB (1); DE (4); ES (3); IL (3); US (43); SL (1); TU (3); UA (3); ME (5)