EUCTR2016-000191-21-PL
Active, not recruiting
Phase 1
A Phase 4 open-label randomized controlled study COmparing the effectiveness of adalimumab iNTROduction and methotrexate dose escaLation in subjects with Psoriatic Arthritis (CONTROL)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Psoriatic Arthritis
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult male or female, \= 18 years of age at screening
- •2\. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by C1ASsification of Psoriatic Arthritis (CASPAR) criteria at the Screening visit
- •3\. Not in MDA at the time of screening, defined as not meeting at least 5 of the following 7 criteria:
- •Tender joint count (TJC) \= 1 out of 68 assessed
- •Swollen joint count (SJC) \= 1 out of 66 assessed
- •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
- •HAQ\-DI score \= 0\.5
- •Tender entheseal points \= 1 out of 8 assessed
Exclusion Criteria
- •1\. Has contraindication(s) to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients (refer to SmPC or prescribing information)
- •2\. Has history of MTX intolerance/toxicity
- •3\. Has medical condition(s) precluding MTX dose increase above 15 mg ew
- •4\. Has had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general
Outcomes
Primary Outcomes
Not specified
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