A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/25/2019 |
Start Date: | June 25, 2015 |
End Date: | December 6, 2017 |
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab
in combination with methotrexate in subjects with moderately to severly active rheumatoid
arthritis who have had an inadequate response to methotrexate.
In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a
subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study
treatment (PF-06410293) at home.
in combination with methotrexate in subjects with moderately to severly active rheumatoid
arthritis who have had an inadequate response to methotrexate.
In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a
subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study
treatment (PF-06410293) at home.
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4
months.
- At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening
and baseline.
- Hs-CRP equal or greater than 8 mg/L.
- Must have received methotrexate for at least 12 weeks and been on a stable dose for at
least 4 weeks prior to the first study dose.
Exclusion Criteria:
- Evidence of untreated or inadequately treated latent or active TB.
- Evidence of uncontrolled, clinically significant diseases, including moderate or
severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
- History of infection requiring hospitalization or parenteral antimicrobial therapy
within 6 months prior to first dose of study drug.
- May have received no more than 2 doses of one biologic therapy (other than adalimumab
or lymphocyte depleting therapy).
- Any second DMARD must be washed out prior to the first study dose.
We found this trial at
50
sites
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