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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-037-14

Enrollment

231

Registered

2014-11-13

Start date

2014-10-15

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Study treatments include tofacitinib 5 mg BID or 10 mg BID, administered orally, as the citrate salt tablet formulation or TNFi (adalimumab 40 mg administered every other week in solution for subcu

Eligibility

Age

50 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Moderate to severe rheumatoid arthritis 2.Taking methotrexate without adequate control of symptoms 3.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

Exclusion criteria: 1.Current or recent infection 2.Clinically significant laboratory abnormalities 3.Pregnancy

Countries

Argentina, Bosnial and Herzegovina, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Estonia, France, Germany, Hungary, Korea South, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, Serbia, Spain, Thailand, Ukraine

Contacts

Public ContactSandra Angles

PFIZER S.A.

Sandra.Angles_OverallOut@pfizer.com6152212

Outcome results