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A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) (REGAIN)

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ClinicalTrials.gov Identifier: NCT01962974
Recruitment Status : Terminated (Cancelled due to low enrollment)
First Posted : October 16, 2013
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Intervention Biological: Golimumab 2 mg/kg IV
Enrollment 7
Recruitment Details  
Pre-assignment Details The study was terminated early due to low recruitment; only 7 participants were enrolled.
Arm/Group Title Golimumab
Hide Arm/Group Description Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
Period Title: Overall Study
Started 7
Completed 0
Not Completed 7
Reason Not Completed
Study termination             7
Arm/Group Title Golimumab
Hide Arm/Group Description Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
60.0  (11.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
7
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24
Hide Description The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.
Arm/Group Title Golimumab
Hide Arm/Group Description:
Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab
Hide Description The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.
Arm/Group Title Golimumab
Hide Arm/Group Description:
Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)
Hide Description The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.
Arm/Group Title Golimumab
Hide Arm/Group Description:
Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Golimumab
Hide Arm/Group Description Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
All-Cause Mortality
Golimumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Golimumab
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Golimumab
Affected / at Risk (%)
Total   0/7 (0.00%) 
The primary limitation for this study was the very low enrolment, ie, 7 participants which led to the early termination of the study.
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: STRATEGIC LEAD
Organization: Janssen Pharmaceuticals
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01962974    
Other Study ID Numbers: CR102117
CNTO148ART3003 ( Other Identifier: Janssen Biotech, Inc. )
2013-001809-91 ( EudraCT Number )
First Submitted: October 11, 2013
First Posted: October 16, 2013
Results First Submitted: December 14, 2016
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017