| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 4 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Arthritis, Rheumatoid |
- 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
Other Name: Humira
- Biological: etanercept
Pre-filled syringe, 50 mg subcutaneous injection, every week
Other Name: Enbrel
|
- Experimental: Treatment Arm 1
Intervention: Drug: tofacitinib
- Experimental: Treatment Arm 2
Intervention: Drug: tofacitinib
- Active Comparator: Treatment Arm 3
TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
Interventions:
- Biological: adalimumab
- Biological: etanercept
|
| Not Provided |
| |
| Recruiting |
| 4400 |
| August 8, 2019 |
| August 8, 2019 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Moderate to severe rheumatoid arthritis
- Taking methotrexate without adequate control of symptoms
- Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)
Exclusion Criteria:
- Current or recent infection
- Clinically significant laboratory abnormalities
- Pregnancy
|
| Sexes Eligible for Study: |
All |
|
| 50 Years and older (Adult, Senior) |
| No |
|
| Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Finland, Hong Kong, Israel, Jordan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Puerto Rico, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States |
| Austria, Czech Republic, Sweden |
| |
| NCT02092467 |
A3921133
2013-003177-99 ( EudraCT Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| November 2017 |
