A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
![]() |
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: NCT02222493 |
Recruitment Status :
Completed
First Posted : August 21, 2014
Results First Posted : September 11, 2017
Last Update Posted : May 30, 2018
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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-06438179 Biological: Infliximab |
Enrollment | 650 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | A total of 1603 participants were screened after signing an informed consent form, of whom 650 participants were randomized to receive study treatment. One (1) participant in the PF-06438179 arm was screened and randomized by 2 different study site personnel, and no data were collected for the participant's second randomization. |
Arm/Group Title | PF-06438179 | Infliximab-EU Remicade (INX) |
---|---|---|
![]() |
Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179. | Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179. |
Period Title: Period 1: First Dose-Week 30 (Pre-dose) | ||
Started | 324 | 326 |
Received Treatment | 323 | 326 |
Completed | 280 | 286 |
Not Completed | 44 | 40 |
Reason Not Completed | ||
Death | 2 | 2 |
Lost to Follow-up | 0 | 1 |
Withdrawal by Subject | 11 | 9 |
Protocol Violation | 5 | 1 |
Insufficient clinical response | 0 | 7 |
Non-compliance with study treatment | 1 | 0 |
Pregnancy | 2 | 0 |
Adverse Event | 18 | 20 |
Other | 4 | 0 |
Randomized but not treated | 1 | 0 |
Period Title: Period 2: Week30 Dosing-Week54(Pre-dose) | ||
Started | 423 | 143 |
Completed | 380 | 126 |
Not Completed | 43 | 17 |
Reason Not Completed | ||
Death | 1 | 0 |
Adverse Event | 22 | 9 |
Other | 3 | 0 |
Non-compliance with study treatment | 1 | 0 |
Withdrawal by Subject | 6 | 4 |
Lost to Follow-up | 1 | 1 |
Insufficient clinical response | 9 | 3 |
Period Title: Period 3: Week 54 Dosing-Week 78 Visit | ||
Started | 505 | 0 |
Completed | 474 | 0 |
Not Completed | 31 | 0 |
Reason Not Completed | ||
Insufficient clinical response | 3 | 0 |
Adverse Event | 14 | 0 |
Other | 4 | 0 |
Non-compliance with study treatment | 1 | 0 |
Withdrawal by Subject | 9 | 0 |
Baseline Characteristics
Arm/Group Title | PF-06438179 | Infliximab-EU Remicade (INX) | Total | |
---|---|---|---|---|
![]() |
Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179. | Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179. | Total of all reporting groups | |
Overall Number of Baseline Participants | 324 | 326 | 650 | |
![]() |
The Intent-to-Treat (ITT) Population was defined as all participants who were randomized to study treatment.
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 324 participants | 326 participants | 650 participants | |
52.8 (13.3) | 52.8 (12.9) | 52.8 (13.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 324 participants | 326 participants | 650 participants | |
Female |
258 79.6%
|
264 81.0%
|
522 80.3%
|
|
Male |
66 20.4%
|
62 19.0%
|
128 19.7%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02222493 |
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: | May 30, 2018 |