CompletedPhase 4

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

United States1,152 participantsStarted 2014-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6

Timeframe: Month 6

Trial details

NCT IDNCT02187055

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2017-12-01

View on ClinicalTrials.gov More Rhematoid Arthritis trials