Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan

NCT00661661 | Completed Phase 3 Results

• 1 other identifier: A3921041
• Study Type: interventional
• Target: 487
• Locations: 1 country
• Sites: 56

Brief Summary

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.

Conditions

Rheumatoid Arthritis

Keywords

Long term open label study in Japan; CP-690; 550; tofacitinib

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.

  Baseline up to Week 288

Secondary Outcomes (22)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

  Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

  Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

  Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

  Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288

• Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

  Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288

Study Arms (1)

CP-690,550

EXPERIMENTAL

Drug: CP-690,550

Interventions

CP-690,550 DRUG

5 mg BID up to 10 mg BID until launch

CP-690,550

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

You may not qualify if:

• Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Sponsors & Collaborators

• Pfizer: lead

Study Sites (56)

National hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

National Hospital Organization Chiba-East Hospital

Chiba, Chiba, 260-8712, Japan

Location

Chiba-ken Saiseikai Narashino Hospital

Narashino, Chiba, 275-8580, Japan

Location

Shimoshizu National Hospital

Yotukaidou, Chiba, 284-0003, Japan

Location

Kondo clinic for rheumatism and orthopaedics

Fukuoka, Fukuoka, 810-0001, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Medical Co.LTA PS Clinic

Fukuoka, Fukuoka, 812-0025, Japan

Location

Aso Iizuka Hospital

Iiduka, Fukuoka, 820-8505, Japan

Location

University of Occupational and Environmental Health Hospital

Kitakyushu, Fukuoka, 807-8555, Japan

Location

St. Mary's Hospital

Kurume, Fukuoka, 830-8543, Japan

Location

SHONO Rheumatism Clinic

Sawara-ku, Fukuoka, 814-0002, Japan

Location

Fukusima Daiichi Hospital

Fukushima, Fukushima, 960-8251, Japan

Location

Inoue Hospital

Takasaki, Gunma, 370-0053, Japan

Location

Higashihiroshima Memorial Hospital

Higashihiroshima, Hiroshima, 739-0002, Japan

Location

Hiroshima Rheumatology Clinic

Hiroshima, Hiroshima, 730-0017, Japan

Location

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, 730-8619, Japan

Location

Katayama Orthopedic Rheumatology Clinic

Asahikawa, Hokkaido, 078-8243, Japan

Location

Sapporo city general hospital

Sapporo, Hokkaido, 060-8604, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Hokkaido Medical Center for Rheumatic Diseases

Sapporo, Hokkaido, 063-0811, Japan

Location

The Hospital of Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Taga General Hospital

Hitachi-shi, Ibaraki, 316-0035, Japan

Location

Tsukuba University Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan, 160-8582, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

Location

Kumamoto Saishunso National Hospital

Koushi, Kumamoto, 861-1196, Japan

Location

Kumamoto Orthopaedic Hospital

Kumamoto, Kumamoto, 862-0976, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

National hospital Organization Mie Chuou Medical Center

Tsu, Mie-ken, 514-1101, Japan

Location

Hikarigaoka Spellman Hospital

Sendai, Miyagi, 983-0833, Japan

Location

Nagasaki University Hospital of Medicine and Dentistry

Nagasaki, Nagasaki, 852-8501, Japan

Location

National Hospital Organization Nagasaki Medical Center

Ohmura, Nagasaki, 856-0835, Japan

Location

Sasebo Chuo Hospital

Sasebo, Nagasaki, 857-1195, Japan

Location

Higami hospital

Kashihara, Nara, 634-0007, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, Niigata, 951-8520, Japan

Location

A Medical Corporation Oribe Rheumatism Internist Clinic

Ōita, Oita Prefecture, 870-0823, Japan

Location

National Hospital Organization Osaka Minami Center

Kawachi-Nagano, Osaka, 586-8521, Japan

Location

The Tazuke Kofukai Medical Research Institute Kitano Hospital

Osaka, Osaka, 530-8480, Japan

Location

Ureshino Medical Center

Ureshino, Saga-ken, 843-0393, Japan

Location

Saitama Medical Center

Kawagoe-shi, Saitama, 350-8550, Japan

Location

Kitasato University Kitasato Institute Medical Center Hospital

Kitamoto, Saitama, 364-8501, Japan

Location

Saitama city hospital

Saitama, Saitama, 336-8522, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Tokyo Women's Medical University Medical Center East

Arakawa-ku, Tokyo, 116-8567, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Tokyo Medical And Dental University Hospital, Faculty of Medicine

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Sasaki Foundation Kyoundo Hospital

Chiyoda-ku, Tokyo, 101-0062, Japan

Location

Juntendo Tokyo Koto Geriatric Medical Center

Koto-ku, Tokyo, 136-0075, Japan

Location

National Hospital Organization Tokyo Medical Center

Meguro-ku, Tokyo, 152-8902, Japan

Location

National Hospital Organization MURAYAMA Medical Center

Musashimurayama-shi, Tokyo, 208-0011, Japan

Location

Fukuhara Hospital

Setagaya-ku, Tokyo, 155-0031, Japan

Location

Tokyo Women's Medical University, Institute of Rheumatology

Shinjyuku-ku, Tokyo, 162-0054, Japan

Location

Sendai Taihaku Hospital

Miyagi, 982-0032, Japan

Location

Related Publications (17)

• Strand V, Schulze-Koops H, Al-Emadi S, Kinch CD, Gruben D, Germino R, Connell CA, Mysler E. Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials. BMJ Open. 2025 Dec 24;15(12):e082366. doi: 10.1136/bmjopen-2023-082366.

  PMID: 41448717 DERIVED

• Pope J, Finckh A, Silva-Fernandez L, Mandl P, Fan H, Rivas JL, Valderrama M, Montoro M. Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention. Open Access Rheumatol. 2024 Jun 11;16:115-126. doi: 10.2147/OARRR.S446431. eCollection 2024.

  PMID: 38883150 DERIVED

• Curtis JR, Wollenhaupt J, Tas SW, Chatzidionysiou K, Wang L, Roberts K, Tsekouras V. Determinants of tofacitinib discontinuation in adult patients with rheumatoid arthritis during long-term extension studies up to 9.5 years. Rheumatol Adv Pract. 2024 May 11;8(2):rkae063. doi: 10.1093/rap/rkae063. eCollection 2024.

  PMID: 38854417 DERIVED

• Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.

  PMID: 37453736 DERIVED

• Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.

  PMID: 36931693 DERIVED

• Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.

  PMID: 36601090 DERIVED

• Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.

  PMID: 36600185 DERIVED

• Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.

  PMID: 36526796 DERIVED

• Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

  PMID: 34870800 DERIVED

• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

  PMID: 33127856 DERIVED

• van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.

  PMID: 33057725 DERIVED

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

  PMID: 32816215 DERIVED

• Fleischmann R, Wollenhaupt J, Takiya L, Maniccia A, Kwok K, Wang L, van Vollenhoven RF. Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. RMD Open. 2017 Dec 18;3(2):e000491. doi: 10.1136/rmdopen-2017-000491. eCollection 2017.

  PMID: 29435359 DERIVED

• Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7.

  PMID: 29417430 DERIVED

• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

  PMID: 28143815 DERIVED

• Yamanaka H, Tanaka Y, Takeuchi T, Sugiyama N, Yuasa H, Toyoizumi S, Morishima Y, Hirose T, Zwillich S. Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study. Arthritis Res Ther. 2016 Jan 28;18:34. doi: 10.1186/s13075-016-0932-2.

  PMID: 26818974 DERIVED

• Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

  PMID: 25047021 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; 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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: April 18, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-04

Locations

JP (56)