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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01962974
Date of registration: 11/10/2013
Prospective Registration: Yes
Primary sponsor: Janssen Biotech, Inc.
Public title: A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) REGAIN
Scientific title: A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
Date of first enrolment: October 2013
Target sample size: 7
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01962974
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Argentina Brazil Canada Colombia Mexico United States
Contacts
Key inclusion & exclusion criteria

Major Inclusion Criteria include (but not limited to):

- Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of
the American Rheumatism Association).

- Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of
methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFa therapy
with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg
every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).

- Disease Activity Score 28 (DAS28) = 3.2 based on Erythrocyte Sedimentation Rate (ESR)
at Week -8 and Week 0.

- Swollen joint count (SJC) = 4 and tender joint count (TJC) = 4 at Week - 8 and at Week
0.

- Prior response confirmed by physician.

Major Exclusion Criteria include (but not limited to):

- Have a history of latent or active granulomatous infection, including histoplasmosis,
or Have a history of latent or active granulomatous infection, including
histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during
the Screening Period.

- Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.

- Have a chest radiograph within 3 months prior to the first administration of study
agent that shows an abnormality suggestive of a malignancy or current active
infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.

- Have previously received more than 1 of the currently approved subcutaneous (SC)
administered anti-TNFa agents, etanercept, certolizumab pegol, golimumab, or
adalimumab.

- Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months
after receiving the last administration of the study agent.

- Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than 242
pounds).



Age minimum: 18 Years
Age maximum: 76 Years
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Intervention(s)
Biological: Golimumab 2 mg/kg IV
Primary Outcome(s)
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24 [Time Frame: Week 24]
Secondary Outcome(s)
Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ) [Time Frame: Week 24]
Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab [Time Frame: Week 24]
Secondary ID(s)
2013-001809-91
CNTO148ART3003
CR102117
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 12/04/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01962974
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