ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

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.
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Biological: PF-06410293
Biological: Adalimumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1231 potential participants were screened after signing an informed consent form, of whom 597 participants were randomized to receive study treatment.

Reporting Groups
  Description
PF-06410293 Participants received subcutaneous (SC) injection of PF-06410293 at a dose of 40 mg every other week.
Adalimumab-EU Participants received subcutaneous (SC) injection of adalimumab (adalimumab sourced from the European Union) at a dose of 40 mg every other week.

Participant Flow:   Overall Study
    PF-06410293   Adalimumab-EU
STARTED   297   300 
Received Treatment   297   299 
COMPLETED   286   273 
NOT COMPLETED   11   27 
Discontinued from treatment and study                5                12 
Withdrew treatment; continued in study                6                14 
Randomized but not treated                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intent-to-Treat (ITT) population was defined as all participants who were randomized to study treatment.

Reporting Groups
  Description
PF-06410293 Participants received subcutaneous (SC) injection of PF-06410293 at a dose of 40 mg every other week.
Adalimumab-EU Participants received subcutaneous (SC) injection of adalimumab (adalimumab sourced from the European Union) at a dose of 40 mg every other week.
Total Total of all reporting groups

Baseline Measures
   PF-06410293   Adalimumab-EU   Total 
Overall Participants Analyzed 
[Units: Participants]
 297   300   597 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.5  (13.6)   53.5  (12.9)   52.5  (13.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      241  81.1%      229  76.3%      470  78.7% 
Male      56  18.9%      71  23.7%      127  21.3% 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only data from the first 26-week treatment period (from baseline to Week 26 pre-dose) are presented for this ongoing study. This report will be updated after completion of the study.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Submitted: June 19, 2015
First Posted: June 24, 2015
Results First Submitted: August 29, 2017
Results First Posted: September 26, 2017
Last Update Posted: March 7, 2018