Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04230213
Previous Study | Return to List | Next Study

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 : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 14, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date June 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Cmax obtained during week 30-32. [ Time Frame: during week 30-32 ]
  • AUCt obtained during week 30-32. [ Time Frame: during week 30-32 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Other serum adalimumab PK parameters, including Tmax. [ Time Frame: Baseline through week 32 ]
  • Number of participants with treatment related adverse events (TEAEs). [ Time Frame: Baseline through Week 36 ]
  • Percent of participants with Anti-drug Antibodies (ADA)/Neutralizing Antibodies (Nab) over time. [ Time Frame: Baseline through week 32 ]
  • Other serum adalimumab PK parameters, including Cav. [ Time Frame: Baseline through Week 32 ]
  • Other serum adalimumab PK parameters, including CL/F. [ Time Frame: Baseline through Week 32 ]
  • Other serum adalimumab PK parameters, including Ctrough. [ Time Frame: Baseline through Week 32 ]
  • Number of participants with clinically significant change in laboratory test. [ Time Frame: Baseline through Week 36 ]
  • Percent of participants with ADA/Nab titers over time. [ Time Frame: Baseline through Week 32 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Official Title  ICMJE A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: PF-06410293
    SC injection
  • Drug: adalimumab
    SC injection
    Other Name: Humira ®
Study Arms  ICMJE
  • Experimental: Treatment Arm 1
    Subcutaneous (SC) injection given every other week
    Interventions:
    • Drug: PF-06410293
    • Drug: adalimumab
  • Active Comparator: Treatment Arm 2
    SC injection given every other week
    Intervention: Drug: adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2020)
420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 9, 2021
Estimated Primary Completion Date June 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Bosnia and Herzegovina,   Bulgaria,   Czechia,   Lithuania,   Poland,   Russian Federation,   Serbia,   South Africa,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04230213
Other Study ID Numbers  ICMJE B5381012
2019-000284-24 ( EudraCT Number )
B5381012 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP