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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: Completed Phase 4 study, sponsored by AbbVie.
NCT02814175 is a Phase 4 study that has completed, run by AbbVie. The registered enrollment target is 246 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Minimal disease activity (MDA) for psoriatic arthritis (PsA) was defined as fulfilling at least 5 of the following 7 criteria: tender and swollen joint counts (TJC) ≤ 1 (out of TJC68 assessed in this study), swollen joint count (SJC) ≤ 1 (out of SJC66 assessed in this study), Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3; Patient's assessment of pain visual analogue scale (VAS) ≤ 15, Patient's global assessment of disease activity (PtGA) VAS ≤ 20, Health Assessment
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 |
What the finished NCT02814175 record still lists
NCT02814175 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which methotrexate (MTX) is the first listed.
NCT02814175 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02814175's enrollment target sits among peer trials
246 356th of 2000 higher than 1,644 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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