Status:
COMPLETED
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Lead Sponsor:
Pfizer
Conditions:
Rhematoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 tofacitin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
1152 Patients enrolled
Trial Details
Trial ID
NCT02187055
Start Date
August 1 2014
End Date
December 1 2016
Last Update
June 27 2018
Active Locations (215)
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1
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States, 35801
2
Arthrocare, Arthritis Care & Research, PC
Gilbert, Arizona, United States, 85234
3
Medvin Clinical Research
Covina, California, United States, 91722
4
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835