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Clinical Trials List

Protocol NumberA3921187

2014-07-31 - 2017-03-30

Others

Terminated6

A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis

  • Sponsor

    Pfizer Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/19

Investigators and Locations

Principal Investigator 林孝義 Division of Rheumatology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Shue-Fen Lo 風濕免疫科
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 魏正宗 Division of Rheumatology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 蔡世滋 風濕免疫科
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 曾瑞成 Division of Rheumatology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Wen Chan Tsai 風濕免疫科
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Severely Active Rheumatoid Arthritis

Objectives

To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.

Test Drug

Tofacitinib (Xeljanz)

Active Ingredient

Tofacitinib

Dosage Form

Dosage

5 mg/tab

Endpoints

Primary Outcome Measures :
Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 [ Time Frame: Month 6 ]
ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.

Inclution Criteria

Inclusion Criteria:

Have moderate to severe rheumatoid arthritis
On methotrexate but inadequately controlled
Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
Subjects must use contraception

Exclusion Criteria

Exclusion Criteria:

Subjects who have been previously treated with adalimumab or Tofacitinib
Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
Subjects with specific laboratory test abnormalities
Subjects with specific types of infections

The Estimated Number of Participants

  • Taiwan

    47 participants

  • Global

    1080 participants

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