A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

NCT02281552 | Completed Phase 3 Results DMC

• 2 other identifiers: A3921215TOFACITINIB QD P3
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 36

Brief Summary

This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.

Conditions

Rheumatoid Arthritis

Keywords

Tofacitinib, CP-690,550, Janis kinase, JAK inhibitor, modified release, Xeljanz

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12

  DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, CRP (milligrams per liter \[mg/L\]) and patient global assessment of disease activity on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \[less than or equal to\] \<= 3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) less than (\<) 2.6 implied remission.

  Baseline, Week 12

Secondary Outcomes (14)

• Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12

  Baseline, Week 12

• Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12

  Week 12

• Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12

  Week 12

• Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12

  Week 12

• Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12

  Week 12

Other Outcomes (2)

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

  Baseline up to 12 weeks

• Number of Participants With Clinically Significant Laboratory Test Abnormalities

  Baseline up to 12 weeks

Study Arms (2)

tofacitinib modified release tablet

EXPERIMENTAL

Drug: Tofacitinib

tofacitinib immediate release tablet

ACTIVE COMPARATOR

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks

tofacitinib modified release tablet

Eligibility Criteria

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

You may qualify if:

• diagnosis of rheumatoid arthritis
• currently taking a stable dose of methotrexate
• no evidence of active or latent or inadequately treated tuberculosis

You may not qualify if:

• evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease
• clinically significant infections within the past 6 months

Sponsors & Collaborators

• Pfizer: lead

Study Sites (36)

Japanese Red Cross Nagoya Daiichi Hospital

Nagoya, Aichi-ken, 453-8511, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

National Hospital Organization Toyohashi Medical Center

Toyohashi, Aichi-ken, 440-8510, Japan

Location

Yamada Rheumatology Clinic

Matsuyama, Ehime, 790-0905, Japan

Location

St. Mary's Hospital

Kurume, Fukuoka, 830-8543, Japan

Location

Gunma Rheumatism Clinic

Takasaki-shi, Gunma, 370-0004, Japan

Location

Inoue Hospital

Tohrimachi, Takasaki, Gunma, 370-0053, Japan

Location

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, 730-8619, Japan

Location

National Hospital Organization Asahikawa Medical Center

Asahikawa, Hokkaido, 070-8644, Japan

Location

Katayama Orthopaedic Rheumatology Clinic

Asahikawa, Hokkaido, 078-8243, Japan

Location

Yoshida orthopaedics and rheumatologyclinic

Morioka, Iwate, 020-0015, Japan

Location

Komagamine Rheumatoid Orthopaedic Clinic

Morioka, Iwate, 020-0034, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan

Location

Osaki Citizen Hospital

Oosaki, Miyagi, 989-6183, Japan

Location

Tohoku University Hospital/ Department of Hematology and Rheumatology

Sendai, Miyagi, 9808574, Japan

Location

Nagano Red Cross Hospital

Nagano, Nagano, 380-8582, Japan

Location

Sasebo Chuo Hospital

Sasebo, Nagasaki, 857-1195, Japan

Location

National Hospital Organization Ureshino Medical Center

Ureshino-shi, Saga-ken, 843-0393, Japan

Location

Soshigayaokura clinic

Setagaya-ku, Tokyo, 157-0073, Japan

Location

Showa University Hospital

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Honjo Rheumatism Clinic

Takaoka-shi, Toyama, 933-0874, Japan

Location

Miyasato Clinic

Shūnan, Yamaguchi, 745-0824, Japan

Location

National Hospital Organization Chiba-East Hospital

Chiba, 260-8712, Japan

Location

Sugimoto rheumatology and internal medicine clinic

Fukui, 910-0068, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

SHONO Rheumatism Clinic

Fukuoka, 814-0002, Japan

Location

Sagawa Akira Rheumatology Clinic

Hokkaido, 060-0001, Japan

Location

Matsubara Mayflower Hospital

Hyōgo, 673-1462, Japan

Location

Yokohama Minami Kyosai Hospital

Kanagawa, 236-0037, Japan

Location

Kumamoto Orthopaedic Hospital

Kumamoto, 862-0976, Japan

Location

Japanese Red Cross Kyoto Daiichi Hospital

Kyoto, 605-0981, Japan

Location

Oribe Clinic of Rheumatology and Internal Medicine

Ōita, 870-0823, Japan

Location

Otsuka Clinic of Rheumatism and Medicine

Ōita, 870-1155, Japan

Location

Rabbit Clinic

Saitama, 336-0911, Japan

Location

Hirose Clinic

Saitama, 359-1111, Japan

Location

Related Publications (5)

• 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

• Tanaka Y, Sugiyama N, Toyoizumi S, Lukic T, Lamba M, Zhang R, Chen C, Stock T, Valdez H, Mojcik C, Fan H, Deng C, Yuasa H. Modified- versus immediate-release tofacitinib in Japanese rheumatoid arthritis patients: a randomized, phase III, non-inferiority study. Rheumatology (Oxford). 2019 Jan 1;58(1):70-79. doi: 10.1093/rheumatology/key250.

  PMID: 30137547 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: November 18, 2014
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: October 12, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (36)