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A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02480153
First received: June 19, 2015
Last updated: June 5, 2017
Last verified: June 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Rheumatoid Arthritis | Biological: PF-06410293 Biological: Adalimumab | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: 12 Weeks ]ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Secondary Outcome Measures:
- Number of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: 26 Weeks ]ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
- Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: 26 Weeks ]ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
- Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: 26 Weeks ]ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
- Disease Activity Score Based on 28-joints Count (DAS28)-4(CRP) [ Time Frame: 26 Weeks ]
- DAS Remission (≤2.6) [ Time Frame: 26 Weeks ]
- EULAR Response and ACR / EULAR Remission [ Time Frame: 26 Weeks ]
- Change from baseline in individual components of ACR response [ Time Frame: 26 Weeks ]
- Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab) [ Time Frame: 26 Weeks ]
- Serum drug concentration [ Time Frame: 26 Weeks ]
| Estimated Enrollment: | 560 |
| Actual Study Start Date: | June 25, 2015 |
| Estimated Study Completion Date: | December 6, 2017 |
| Primary Completion Date: | August 31, 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-06410293 |
Biological: PF-06410293
PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Other Name: Adalimumab-Pfizer
|
| Active Comparator: Adalimumab |
Biological: Adalimumab
Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Other Name: Adalimumab-European Union, Humira
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02480153
Show 183 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02480153
Show 183 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT02480153 History of Changes |
| Other Study ID Numbers: |
B5381002 B5381002, REFLECTIONS B538-02 2014-000352-29 ( EudraCT Number ) ADALIMUMAB ( Other Identifier: Alias Study Number ) |
| Study First Received: | June 19, 2015 |
| Last Updated: | June 5, 2017 |
Keywords provided by Pfizer:
|
Phase 3 adalimumab rheumatoid arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Adalimumab Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on July 17, 2017