A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug

Phase 1

• Conditions: Moderately to Severely Active Psoriatic Arthritis; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-004130-24-EE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1705

Inclusion Criteria

1. Male or female, at least 18 years of age
2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR)
3. Subject has active disease at Baseline defined as = 3 tender joints (based on 68 joint counts) and = 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
5. Subject is on current treatment with = 2 nonbiologic DMARDs
6. Subject has had an inadequate response to previous or current treatment with at least 1 non-biologic DMARD (MTX, SSZ, LEF, cyclosporine, apremilast, bucillamine, or iguratimod), or subject has an intolerance to or contraindication for DMARDs
7. Presence of either at Screening:
• = 1 erosion on x-ray
• hs-CRP > laboratory-defined upper limit of normal (ULN)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1468
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 237

Exclusion Criteria

1. Prior exposure to any Janus Kinase (JAK) inhibitor
2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified