An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Status: | Completed |
---|---|
Conditions: | Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/29/2018 |
Start Date: | August 2014 |
End Date: | December 2016 |
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
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.
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.
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:
- 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
We found this trial at
61
sites
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Los Angeles, California 90033
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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