Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Psoriatic Arthritis

Phase 1

• Conditions: Active Psoriatic Arthritis; MedDRA version: 18.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-002798-80-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-25
• Last Update Posted: 25 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 656

Inclusion Criteria

• Subjects at least 18 years of age who have a diagnosis of PsA by Classification Criteria for Psoriatic Arthritis (CASPAR)
• Subjects have active PsA as shown by a minimum of = 3 swollen joints and = 3 tender joints (66/68 joint counts) at screening and randomization/Day 1 (prior to study drug administration). At least one of the swollen joints must be in the digit of the hand or foot.
• Subjects with at least one confirmed = 2 cm target lesion of plaque psoriasis in a region of the body that can be evaluated.
• Subjects must have had an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD).
• Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for any reason (inadequate response, intolerance or other).
• Subjects may enroll on certain concomitant non-biologic DMARDs (methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) provided the medication has been used for at least 3 months with a stable dose for at least 28 days prior to randomization (Day 1).
• If using oral corticosteroids (= 10 mg mg/day prednisone equivalent), dose must be stable =14 days prior to randomization (Day 1).
• Subjects may enroll on systemic retinoids (eg, acitretin) provided the medication has been used for at least 3 months with a stable dose for at least 28 days prior to randomization (Day 1).

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 590
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

• Subjects with guttate, pustular, or erythrodermic psoriasis
• Subjects who have had prior exposure to abatacept (CTLA 4Ig)
• Subjects who have been exposed to any investigational drug within 4 weeks or 5 half lives, whichever is longer
• Prior use of apremilast or ustekinumab
• Female subjects who had a breast cancer screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
• Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Subjects with carcinoma in situ, treated with definitive surgical intervention prior to study enrollment are allowed.
• Subjects with any bacterial infection within the last 60 days prior to screening (enrollment), unless treated and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis).
• Subjects at risk for tuberculosis
• Subjects with herpes zoster that resolved less than 2 months prior to enrollment
• Subjects with evidence of active or latent bacterial, active viral, or serious latent viral infections at the time of enrollment, including subjects with evidence of Immunodeficiency Virus (HIV) infection
• Subjects who are not currently treated with a non-biologic DMARD and have clinical or radiographic evidence of arthritis mutilans (eg, digital telescoping or pencil-in-cup” radiographic changes)
• Subjects who have taken >2 TNFis
• Subjects who have received TNFi therapy within 8 weeks for adalimumab, etanercept, or certolizumab or within 12 weeks for infliximab or golimumab
• Subjects who have discontinued a non-biologic DMARD or systemic retinoid within four weeks or five half-lives, whichever is longer, prior to randomization (Day 1)
• Use of any of the following within 28 days or five half lives whichever is longer prior to randomization (Day 1): cyclosporine A, oral tacrolimus, mycophenolate mofetil (MMF), hydroxyurea, fumaric acid esters, paclitaxel, 6-thioguanine, 6-mercatopurine, or tofacitinib

Study & Design

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