Trials / Completed
CompletedNCT02092467
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 4,372 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tofacitinib | Oral tablet, 5 mg BID |
| DRUG | tofacitinib | Oral tablet, 10 mg BID |
| BIOLOGICAL | adalimumab | Pre-filled syringe, 40 mg subcutaneous injection, every other week |
| BIOLOGICAL | etanercept | Pre-filled syringe, 50 mg subcutaneous injection, every week |
Timeline
- Start date
- 2014-03-14
- Primary completion
- 2020-07-22
- Completion
- 2020-07-22
- First posted
- 2014-03-20
- Last updated
- 2021-08-17
- Results posted
- 2021-08-17
Locations
345 sites across 30 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Finland, Hong Kong, Israel, Jordan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Puerto Rico, Russia, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02092467. Inclusion in this directory is not an endorsement.