RISANKIZUMAB for Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.\n- Subject has active disease at Baseline\n- Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit.\n- Presence of either at Screening: 1. ≥ 1 erosion on radiograph as determined by central imaging review or; 2. hs-CRP ≥ 3.0 mg/L.\n- Subject must have demonstrated an inadequate response (lack of efficacy after minimum 12 week duration of therapy) to previous or current treatment with at least 1 csDMARD at maximally tolerated dose."}

Exclusion criteria

• {"criterion_text":"- Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.\n- Subject has a known hypersensitivity to Risankizumab.\n- Subject has previous treatment with biologic agent."}

Primary endpoints

• {"endpoint_text":"- Proportion of subjects achieving ACR 20 response (ACR20) at Week 24.","definition_or_measurement_approach":"Assessed as the proportion of subjects achieving ACR20 response at Week 24."}

Secondary endpoints

• {"endpoint_text":"- Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at Week 24.","definition_or_measurement_approach":"Change from Baseline in HAQ-DI at Week 24."}
• {"endpoint_text":"- Proportion of subjects achieving PASI 90 response at Week 24 (in the subset of subjects with a body surface area [BSA] ≥ 3% at Baseline.","definition_or_measurement_approach":"Proportion achieving PASI 90 at Week 24 in subset with BSA ≥ 3% at Baseline."}
• {"endpoint_text":"- Proportion of subjects achieving ACR20 at Week 16.","definition_or_measurement_approach":"Proportion achieving ACR20 at Week 16."}
• {"endpoint_text":"- Proportion of subjects achieving MDA at Week 24.","definition_or_measurement_approach":"Proportion achieving Minimal Disease Activity (MDA) at Week 24."}
• {"endpoint_text":"- Change from Baseline in modified Nail Psoriasis Severity Index (mNAPSI) at Week 24 in the subset of subjects with nail PsO at Baseline.","definition_or_measurement_approach":"Change from Baseline in mNAPSI at Week 24 in subset with nail psoriasis at Baseline."}
• {"endpoint_text":"- Change from Baseline in Physician Global Assessment of Fingernail Psoriasis (PGA-F) at Week 24 in the subset of subjects with nail PsO at Baseline.","definition_or_measurement_approach":"Change from Baseline in PGA-F at Week 24 in subset with nail psoriasis at Baseline."}
• {"endpoint_text":"- Proportion of subjects with resolution of enthesitis (Leeds Enthesitis Index [LEI] = 0) at Week 24 in subjects with enthesitis at Baseline.","definition_or_measurement_approach":"Proportion with LEI = 0 at Week 24 among those with enthesitis at Baseline."}
• {"endpoint_text":"- Proportion of subjects with resolution of dactylitis (Leeds Dactylitis Index [LDI] = 0) at Week 24 in subjects with dactylitis at Baseline.","definition_or_measurement_approach":"Proportion with LDI = 0 at Week 24 among those with dactylitis at Baseline."}
• {"endpoint_text":"- Change from Baseline in modified Total Sharp Score (PsA mTSS) at Week 24.","definition_or_measurement_approach":"Change from Baseline in PsA modified Total Sharp Score at Week 24."}
• {"endpoint_text":"- Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24.","definition_or_measurement_approach":"Change from Baseline in SF-36 PCS at Week 24."}
• {"endpoint_text":"- Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) Questionnaire at Week 24.","definition_or_measurement_approach":"Change from Baseline in FACIT-Fatigue score at Week 24."}
• {"endpoint_text":"- Proportion of subjects achieving ACR50 response at Week 24.","definition_or_measurement_approach":"Proportion achieving ACR50 at Week 24."}
• {"endpoint_text":"- Proportion of subjects achieving ACR70 response at Week 24.","definition_or_measurement_approach":"Proportion achieving ACR70 at Week 24."}

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Perceptive Informatics Inc.

Responsibilities

Medical Imaging

Name

WCG Clinical Inc.

Responsibilities

ACI Adjudication Committee

Name

Labcorp Central Laboratory Services S.a.r.l.

Name

Medpoint Communications Inc.

Responsibilities

Document Portal

Name

Signant Health Global LLC

Name

Endpoint Clinical Inc.

Third parties

• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"ACI Adjudication Committee","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medpoint Communications Inc.","duties_or_roles":"Document Portal","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}