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Trial record 1 of 1 for:    REFLECTIONS B537-02
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A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222493
First Posted: August 21, 2014
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

Condition Intervention Phase
Rheumatoid Arthritis Biological: PF-06438179 Biological: Infliximab Phase 3

Study Type: Interventional
Study Design: 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-06438179 And Infliximab 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 at Week 14 in the Intent-to-Treat (ITT) Population [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 12, and Week 14 ]
    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).


Enrollment: 650
Actual Study Start Date: August 26, 2014
Study Completion Date: June 1, 2017
Primary Completion Date: June 29, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06438179 Biological: PF-06438179
PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Other Name: Infliximab-Pfizer
Active Comparator: Infliximab Biological: Infliximab
Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Other Name: Infliximab-EU, Remicade

  Eligibility

Information from the National Library of Medicine

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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 10 mg/L.

Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.

Exclusion Criteria:

Evidence of untreated or inadequately treated latent or active TB.

Evidence or history of moderate or severe heart failure (NYHA Class III/IV)

Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.

  Contacts and Locations
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): NCT02222493


  Show 184 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: NCT02222493     History of Changes
Other Study ID Numbers: B5371002
REFLECTIONS B537-02 ( Other Identifier: Alias ID )
2013-004148-49 ( EudraCT Number )
First Submitted: August 19, 2014
First Posted: August 21, 2014
Results First Submitted: June 26, 2017
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: August 2017

Keywords provided by Pfizer:
Phase 3
infliximab
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
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
Gastrointestinal Agents