Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis
NCT ID: NCT01860976
Last Updated: 2022-04-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
489 participants
INTERVENTIONAL
2013-06-17
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
NCT00534313
Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00292396
Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
NCT03881059
A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00570986
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
NCT01989468
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abatacept
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
Placebo
Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abatacept
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, United States
Arthritis Asso & Osteo Ctr Of Colorado Springs
Colorado Springs, Colorado, United States
Joao Nascimento
Bridgeport, Connecticut, United States
New England Research Associates, Llc
Trumbull, Connecticut, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Klein And Associates, M.D., Pa
Hagerstown, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Box Arthritis And Rheumatology Of The Carolinas, Pllc
Charlotte, North Carolina, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, United States
Clinical Research Center Of Reading, Llc
Wyomissing, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Rheumatology Consultants Pllc
Knoxville, Tennessee, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Arthritis Northwest
Spokane, Washington, United States
Local Institution
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Instituto de Asistencia Reumatologica Integral
San Fernando, Buenos Aires, Argentina
Caici
Rosario, Santa Fe Province, Argentina
Centro Medico Privado De Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Instituto De Rehabilitacion Psicofisica
Buenos Aires, , Argentina
Instituto Reumatologico Strusberg
Córdoba, , Argentina
Local Institution
Juiz de Fora, Minas Gerais, Brazil
Local Institution
Curitiba, Paraná, Brazil
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Groupe De Recherche En Rhumatologie Et Maladies Osseuses
Québec, Quebec, Canada
Local Institution
Viña del Mar, Región de Valparaíso, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Santiago, , Chile
Riesgo De Fractura
Bogota, Cundinamarca, Colombia
Servimed E.U
Bucaramanga, , Colombia
Clinica de Artritis Temprana
Cali, , Colombia
Local Institution
Prague, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Chambray-lès-Tours, , France
Local Institution
Lille, , France
Local Institution
Montpellier, , France
Local Institution
Poitiers, , France
Local Institution
Strasbourg, , France
Local Institution
Bad Abbach, , Germany
Local Institution
Erlangen, , Germany
Local Institution
Freiburg im Breisgau, , Germany
Local Institution
Hamburg, , Germany
Local Institution
München, , Germany
Local Institution
Ratingen, , Germany
Local Institution
Trier, , Germany
Local Institution
Athens, , Greece
Local Institution
Crete, , Greece
Local Institution
Ashkelon, , Israel
Local Institution
Haifa, , Israel
Local Institution
Ramat Gan, , Israel
Local Institution
Tel Aviv, , Israel
Local Institution
Florence, , Italy
Local Institution
Milan, , Italy
Local Institution
Palermo, , Italy
Local Institution
Viale Europa Cantanzaro, , Italy
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Zapopan, Jalisco, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Monterrey, N.l., Nuevo León, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Aguascalientes, , Mexico
Clinica San Felipe
Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, , Peru
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, , Peru
Local Institution
Elblag, Warminsko-mazurski, Poland
Local Institution
Dąbrówka, , Poland
Local Institution
Mysłowice, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution
Pinelands, Cape Town, Western Cape, South Africa
Local Institution
Stellenbosch, Western Cape, South Africa
Local Institution
A Coruña, , Spain
Local Institution
Santander, , Spain
Local Institution
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ. Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial. RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.
Strand V, Alemao E, Lehman T, Johnsen A, Banerjee S, Ahmad HA, Mease PJ. Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial. Arthritis Res Ther. 2018 Dec 6;20(1):269. doi: 10.1186/s13075-018-1769-7.
Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017 Sep;76(9):1550-1558. doi: 10.1136/annrheumdis-2016-210724. Epub 2017 May 4.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM101-332
Identifier Type: -
Identifier Source: org_study_id
2012-002798-80
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.