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A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230213
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: PF-06410293 Drug: adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : February 3, 2022
Estimated Study Completion Date : February 3, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Treatment Arm 1
Subcutaneous (SC) injection given every other week
Drug: PF-06410293
SC injection

Drug: adalimumab
SC injection
Other Name: Humira ®

Active Comparator: Treatment Arm 2
SC injection given every other week
Drug: adalimumab
SC injection
Other Name: Humira ®




Primary Outcome Measures :
  1. Cmax obtained during week 30-32. [ Time Frame: during week 30-32 ]
  2. AUCt obtained during week 30-32. [ Time Frame: during week 30-32 ]

Secondary Outcome Measures :
  1. Other serum adalimumab PK parameters, including Tmax. [ Time Frame: Baseline through week 32 ]
  2. Number of participants with treatment related adverse events (TEAEs). [ Time Frame: Baseline through Week 36 ]
  3. Percent of participants with Anti-drug Antibodies (ADA)/Neutralizing Antibodies (Nab) over time. [ Time Frame: Baseline through week 32 ]
  4. Other serum adalimumab PK parameters, including Cav. [ Time Frame: Baseline through Week 32 ]
  5. Other serum adalimumab PK parameters, including CL/F. [ Time Frame: Baseline through Week 32 ]
  6. Other serum adalimumab PK parameters, including Ctrough. [ Time Frame: Baseline through Week 32 ]
  7. Number of participants with clinically significant change in laboratory test. [ Time Frame: Baseline through Week 36 ]
  8. Percent of participants with ADA/Nab titers over time. [ Time Frame: Baseline through Week 32 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
  • Moderately to severely active RA based on local standard of care.

Exclusion Criteria:

-Evidence of untreated or inadequately treated latent or active TB.


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): NCT04230213


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 54 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04230213    
Other Study ID Numbers: B5381012
2019-000284-24 ( EudraCT Number )
B5381012 ( Other Identifier: Alias Study Number )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents