Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01962974 · ClinicalTrials.gov registry record · Phase 3
A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
A Phase 3 study, sponsored by Janssen Biotech.
- Terminated
- Registry status
- Phase 3
- Development phase
- 7
- Enrollment target
NCT01962974 is a Phase 3 study that was terminated before completion, run by Janssen Biotech. The registered enrollment target is 7 participants.
The verdict
NCT01962974, a Phase 3 study, was terminated before completion, sponsored by Janssen Biotech.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease control (defined as an erythrocyte sedimentation rate \[ESR\]-based Disease Activity Score in 28 joints \[DAS28\] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα 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. To be eligible for participation, subjects must have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, who have since exhibited a diminished response despite continued treatment. It is estimated that 200 subjects will be enrolled in the study at approximately 85 global sites.
Interventions
- BIOLOGICAL Golimumab 2 mg/kg IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01962974
The ClinicalTrials.gov registry entry for NCT01962974 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Biotech, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Golimumab 2 mg/kg IV is the first listed.
NCT01962974 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01962974 about?
NCT01962974 is a clinical study titled "A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)". This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease control (defined as an erythrocyte sedimentation rate \[ESR\]-based Disease Activity Score in 28 joints \[DAS28\] ≥ 3....
What is the current status of trial NCT01962974?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2013-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01962974?
The interventions under investigation include: Golimumab 2 mg/kg IV (BIOLOGICAL).
Who is sponsoring clinical trial NCT01962974?
This trial is sponsored by Janssen Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.