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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).

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ClinicalTrials.gov Identifier: NCT02480153
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : September 26, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: PF-06410293 Biological: Adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 597 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : June 25, 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 in the Intent-to-Treat (ITT) Population [ Time Frame: Week 0, week 2, week 4, week 6, week 8 and week 12 ]
    ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: participant's assessment of arthritis pain; participant's global assessment of arthritis; physician's global assessment of arthritis; high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480153


  Show 182 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

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 )
First Posted: June 24, 2015    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: March 7, 2018
Last Verified: March 2018

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