Phase 4
Completed N=245
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
Source: ClinicalTrials.gov NCT02814175 ↗Enrolled (actual)
245
Serious AEs
1.9%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1) — 13.1; 41.5 percentage of participants — p=< 0.001
◆ Published Evidence
Established
21citations · ~5 / year
Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 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.
Linked Publications
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Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1) |
13.1; 41.5 | < 0.001 sig |
| SECONDARY Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1) |
-3.1; -5.9 | — |
| SECONDARY Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1) |
-0.9; -2.8 | — |
| SECONDARY Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1) |
-0.9; -2.0 | — |
| SECONDARY Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1) |
-1.7; -3.3 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1) |
32.8; 67.5; 16.4; 45.5; 8.2; 30.9 | — |
| SECONDARY Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline |
-1.1; -1.9 | — |
| SECONDARY Percentage of Participants in MDA in Part 2 of the Study (Week 32) |
66.7; 54.9; 80.4; 29.8 | — |
| SECONDARY Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1) |
-1.2; -2.8 | — |
| SECONDARY Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1) |
4.4; 8.9; 1.3; 4.4 | — |
| SECONDARY Change in HAQ-DI Score From Baseline (Part 1) |
-0.3; -0.5 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75/90/100 Response Among Participants With BSA Greater Than or Equal to 3% at Baseline (Part 1) |
31.0; 73.1; 18.4; 57.7; 9.2; 29.5 | — |
| SECONDARY Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1) |
-12.1; -28.2 | — |
Eligibility Criteria
Inclusion Criteria
- PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
- Not in MDA at the time of screening
- Has 3 or more tender and 3 or more swollen joints
- Treated with methotrexate 15 mg (weekly) for at least 4 weeks
Exclusion Criteria
- Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
- History of methotrexate intolerance/toxicity
- Medical conditions(s) precluding methotrexate dose increase above 15 mg
- Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general
Data sourced from ClinicalTrials.gov (NCT02814175) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.