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NCT02814175 · ClinicalTrials.gov registry record · Phase 4
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
A Phase 4 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 4
- Development phase
- 246
- Enrollment target
NCT02814175 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 246 participants.
The verdict
NCT02814175, a Phase 4 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 246 participants
- Enrollment target
Study Summary
An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.
Interventions
- DRUG methotrexate (MTX)
- BIOLOGICAL adalimumab (ADA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2016-08-05 |
| Est. Completion | 2020-03-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02814175
The ClinicalTrials.gov registry entry for NCT02814175 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which methotrexate (MTX) is the first listed.
NCT02814175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02814175 about?
NCT02814175 is a clinical study titled "A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)". An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomize...
What is the current status of trial NCT02814175?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 246 participants. The study started on 2016-08-05. Estimated completion is 2020-03-19.
What interventions are being tested in trial NCT02814175?
The interventions under investigation include: methotrexate (MTX) (DRUG), adalimumab (ADA) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02814175?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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