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

Completed · Phase 4 · Has a placebo group

Conditions studied: Rhematoid Arthritis

In brief

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.

Key facts

Study ID

NCT02187055

Run by

Pfizer

People needed

1152

Starts

2014-08-01

Expected to finish

2016-12-01

Last updated by the study team

2018-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arthrocare, Arthritis Care & Research, PC — Gilbert, Arizona, United States
• Medvin Clinical Research — Covina, California, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• HealthCare Partners Medical Group — Huntington Beach, California, United States
• Keck Medicine of USC - Division of Rheumatology — Los Angeles, California, United States
• University of Southern California (USC) Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center - Drug Information Center — Los Angeles, California, United States
• UCLA David Geffen School of Medicine, Division of Rheumatology — Los Angeles, California, United States
• Medvin Clinical Research — Placentia, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Medvin Clinical Research — Van Nuys, California, United States
• Medvin Clinical Research — Whittier, California, United States
• Joao M. A. Nascimento — Bridgeport, Connecticut, United States
• AARDS Research, Inc. — Aventura, Florida, United States
• Arthritis and Rheumatic Disease Specialties — Aventura, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Omega Research Consultants, LLC — Orlando, Florida, United States
• Arthritis Center, Inc. — Palm Harbor, Florida, United States
• Gulf Region Clinical Research Institute Llc — Pensacola, Florida, United States
• West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States
• BayCare Medical Group Inc — Tampa, Florida, United States
• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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