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A PHASE 3B/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

A PHASE 3B/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-070-14
Enrollment
47
Registered
2015-05-13
Start date
2015-02-27
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

Drug: Tofacitinib with methotrexate Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other w

Sponsors

PFIZER S.A.,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 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 criteria

Exclusion criteria: • 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

Countries

Argentina, Australia, Bosnial and Herzegovina, Bulgaria, Canada, Chile, Croatia, Czech Republic, Estonia, Germany, Hungary, Israel, Korea South, Latovia, Lithuania, Mexico, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kindgdom, United States

Contacts

Public ContactSara Flores

PFIZER S.A.

sara.flores@pfizer.com6152112

Outcome results

None listed

Source: REPEC (via WHO ICTRP)