A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02814175
• Date of registration: 21/06/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL) CONTROL
• Scientific title: A Phase 4 Open-label Randomized Controlled Study COmparing the Effectiveness of Adalimumab iNTROduction and Methotrexate Dose escaLation in Subjects With Psoriatic Arthritis (CONTROL)
• Date of first enrolment: August 5, 2016
• Target sample size: 246
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02814175
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Czechia, Germany, Italy, Poland, Puerto Rico, Qatar, Spain, United Kingdom, United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

1. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit
and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria

2. Not in MDA at the time of screening

3. Has 3 or more tender and 3 or more swollen joints

4. Treated with methotrexate 15 mg (weekly) for at least 4 weeks

Exclusion Criteria:

1. Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or
its excipients

2. History of methotrexate intolerance/toxicity

3. Medical conditions(s) precluding methotrexate dose increase above 15 mg

4. Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of
action biologic DMARD (bDMARD) or any systemic biologic agent in general



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Intervention(s)

Drug: methotrexate (MTX)

Biological: adalimumab (ADA)

Primary Outcome(s)

Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1) [Time Frame: Week 16]

Secondary Outcome(s)

Change in Dermatology Life Quality Index (DLQI) Score From Baseline (Part 1) [Time Frame: From Day 1 to Week 16]

Change in Psoriatic Arthritis Impact of Disease Score (PsAID) Score From Baseline (Part 1) [Time Frame: From Day 1 to Week 16]

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) [Time Frame: Week 16]

Change in Disease Activity Score 28 (DAS28)-C-reactive Protein (CRP) Score From Baseline (Part 1) [Time Frame: From Day 1 to Week 16]

Change in Psoriatic Arthritis Disease Activity Score (PASDAS) From Baseline (Part 1) [Time Frame: From Day 1 to week 16]

Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline (Part 1) [Time Frame: From Day 1 to Week 16]

Change in HAQ-DI Score From Baseline (Part 1) [Time Frame: From Day 1 to Week 16]

Percentage of Participants Achieving American College of Rheumatology (ACR) 20/50/70 Response (Part 1) [Time Frame: Week 16]

Change in Leeds Enthesitis Index (LEI) From Baseline (Part 1) for Participants With Presence of LEI at Baseline [Time Frame: From Day 1 to Week 16]

Change in Tender Dactylitic Digit Count From Baseline for Participants With Presence of Dactylitis at Baseline (Part 1) [Time Frame: From Day 1 to Week 16]

Percentage of Participants in MDA in Part 2 of the Study (Week 32) [Time Frame: Week 32]

Change in Short Form Health Survey 36 (SF-36) Score From Baseline (Part 1) [Time Frame: From Day 1 to Week 16]

Secondary ID(s)

2016-000191-21

M14-496

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02814175