This trial is active, not recruiting.

Condition psoriatic arthritis
Treatments abatacept, placebo
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date June 2013
End date July 2015
Trial size 424 participants
Trial identifier NCT01860976, 2012-002798-80, IM101-332


The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Abatacept 125 mg/syringe (125 mg/mL) solution subcutaneously once a week for 168 days double blind/197 days open label/365 days long term extension
abatacept Orencia
(Placebo Comparator)
Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind

Primary Outcomes

Proportion of ACR20 responders
time frame: Day 169

Secondary Outcomes

Proportion of Health Assessment Questionnaire (HAQ) responders (a reduction of at least 0.35 from baseline)
time frame: Baseline (Day 1) and Day 169
Proportion of ACR20 responders in the TNFi naive subpopulation
time frame: Day 169
Proportion of ACR20 responders in the TNFi exposed subpopulation
time frame: Day 169
Proportion of non-progressors in total PsA-modified SHS (defined as a change from baseline in total PsA-modified SHS ≤0)
time frame: Baseline (Day 1) and Day 169

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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 excluding the axilla, genitals, groin, palms, and soles - 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) Exclusion Criteria: - Subjects with guttate, pustular, or erythrodermic psoriasis - Subjects who have had prior exposure to Abatacept (CTLA 4Ig) or other CTLA4 therapies - Subjects who have been exposed to any investigational drug within 4 weeks or 5 half lives, whichever is longer - 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 (TB). Specifically, subjects with: - Current clinical, radiographic or laboratory evidence of active TB - A history of active TB within the last 3 years even if it was treated - A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type - Latent TB which was not successfully treated - Subjects with a positive TB screening test indicative of latent TB will not be eligible for the study unless they have no evidence of current TB on chest x-ray at screening and they are actively being treated for TB with isoniazid (INH) or other therapy for latent TB given according to local health authority guidelines (eg: Center for Disease Control). Treatment must have been given for at least 4 weeks prior to randomization (Day 1). These subjects should complete treatment according to local health authority guidelines - Subjects with herpes zoster that resolved less than 2 months prior to enrollment - Subjects with evidence (as measured by the investigator) 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 failed more than 2 TNFi due to inefficacy defined as inadequate response after 3 months treatment at a therapeutic dose - Subjects who have received TNFi therapy within 4 weeks for etanercept or within 8 weeks for adalimumab, certolizumab, infliximab, or golimumab - Subjects who have received prior use of apremilast within 4 weeks, ustekinumab within 20 weeks or briakinumab within 8 weeks - 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

Additional Information

Official title A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis
Description ASTRAEA=Active PSoriaTic ARthritis RAndomizEd TriAl
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.