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

NCT01860976 | Completed Phase 3 Results

• 2 other identifiers: IM101-3322012-002798-80
• Study Type: interventional
• Target: 489
• Locations: 17 countries
• Sites: 82

Brief Summary

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

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of ACR 20 Responders at Day 169

  The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.

  Day 169

Secondary Outcomes (13)

• Proportion of Health Assessment Questionnaire (HAQ) Responders at Day 169

  Baseline to Day 169

• Proportion of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation

  Day 169

• Proportion of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation

  Day 169

• Proportion of Non-progressors in Total PsA-modified SHS at Day 169

  Baseline to Day 169

• Proportion of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%

  Baseline to Day 169

Study Arms (2)

Abatacept

EXPERIMENTAL

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

Drug: Abatacept

Placebo

PLACEBO COMPARATOR

Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind

Drug: Placebo

Interventions

Abatacept DRUG

Also known as: Orencia

Abatacept

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (82)

Arizona Arthritis & Rheumatology Research PLLC

Phoenix, Arizona, 85037, United States

Location

Arthritis Asso & Osteo Ctr Of Colorado Springs

Colorado Springs, Colorado, 80920, United States

Location

Joao Nascimento

Bridgeport, Connecticut, 06606, United States

Location

New England Research Associates, Llc

Trumbull, Connecticut, 06611, United States

Location

Sarasota Arthritis Research Center

Sarasota, Florida, 34239, United States

Location

Klein And Associates, M.D., Pa

Hagerstown, Maryland, 21740, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

St. Paul Rheumatology, P.A.

Eagan, Minnesota, 55121, United States

Location

Box Arthritis And Rheumatology Of The Carolinas, Pllc

Charlotte, North Carolina, 28210, United States

Location

Paramount Medical Research & Consulting, Llc

Middleburg Heights, Ohio, 44130, United States

Location

Health Research Of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania, 18015, United States

Location

Clinical Research Center Of Reading, Llc

Wyomissing, Pennsylvania, 19610, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Rheumatology Consultants Pllc

Knoxville, Tennessee, 37909-1907, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98122, United States

Location

Arthritis Northwest

Spokane, Washington, 99204, United States

Location

Local Institution

Ciudad Autonoma Beunos Aires, Buenos Aires, 1431, Argentina

Location

Instituto de Asistencia Reumatologica Integral

San Fernando, Buenos Aires, 1646, Argentina

Location

Caici

Rosario, Santa Fe Province, 2000, Argentina

Location

Centro Medico Privado De Reumatologia

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Instituto De Rehabilitacion Psicofisica

Buenos Aires, 1428, Argentina

Location

Instituto Reumatologico Strusberg

Córdoba, 5000, Argentina

Location

Local Institution

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Local Institution

Curitiba, Paraná, 80440-080, Brazil

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Groupe De Recherche En Rhumatologie Et Maladies Osseuses

Québec, Quebec, G1V 3M7, Canada

Location

Local Institution

Viña del Mar, Región de Valparaíso, 2520997, Chile

Location

Local Institution

Santiago, Santiago Metropolitan, 0, Chile

Location

Local Institution

Santiago, 7500010, Chile

Location

Riesgo De Fractura

Bogota, Cundinamarca, Colombia

Location

Servimed E.U

Bucaramanga, Colombia

Location

Clinica de Artritis Temprana

Cali, Colombia

Location

Local Institution

Prague, 128 50, Czechia

Location

Local Institution

Prague, 140 00, Czechia

Location

Local Institution

Prague, 148 00, Czechia

Location

Local Institution

Chambray-lès-Tours, 37170, France

Location

Local Institution

Lille, 59037, France

Location

Local Institution

Montpellier, 34295, France

Location

Local Institution

Poitiers, 86021, France

Location

Local Institution

Strasbourg, 67098, France

Location

Local Institution

Bad Abbach, 93077, Germany

Location

Local Institution

Erlangen, 91054, Germany

Location

Local Institution

Freiburg im Breisgau, 79106, Germany

Location

Local Institution

Hamburg, 22081, Germany

Location

Local Institution

München, 80336, Germany

Location

Local Institution

Ratingen, 40878, Germany

Location

Local Institution

Trier, 54292, Germany

Location

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Athens, 11527, Greece

Location

Local Institution

Crete, 71110, Greece

Location

Local Institution

Ashkelon, 78278, Israel

Location

Local Institution

Haifa, 34362, Israel

Location

Local Institution

Ramat Gan, 52621, Israel

Location

Local Institution

Tel Aviv, 64239, Israel

Location

Local Institution

Florence, 50139, Italy

Location

Local Institution

Milan, 20122, Italy

Location

Local Institution

Palermo, Italy

Location

Local Institution

Viale Europa Cantanzaro, 88100, Italy

Location

Local Institution

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution

Zapopan, Jalisco, 45190, Mexico

Location

Local Institution

Mexico City, Mexico City, 06090, Mexico

Location

Local Institution

Monterrey, N.l., Nuevo León, 64460, Mexico

Location

Local Institution

Mérida, Yucatán, 97000, Mexico

Location

Local Institution

Mérida, Yucatán, 97070, Mexico

Location

Local Institution

Aguascalientes, 20127, Mexico

Location

Clinica San Felipe

Lima, LIMA 11, Peru

Location

Hospital Nacional Guillermo Almenara Irigoyen

Lima, LIMA 13, Peru

Location

Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

Lima, LIMA 33, Peru

Location

Local Institution

Elblag, Warminsko-mazurski, 82-300, Poland

Location

Local Institution

Dąbrówka, 62-069, Poland

Location

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Mysłowice, 41-400, Poland

Location

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Warsaw, 01-518, Poland

Location

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Pretoria, Gauteng, 0002, South Africa

Location

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Pretoria, Gauteng, 0084, South Africa

Location

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Cape Town, Western Cape, 7500, South Africa

Location

Local Institution

Pinelands, Cape Town, Western Cape, 7405, South Africa

Location

Local Institution

Stellenbosch, Western Cape, 7600, South Africa

Location

Local Institution

A Coruña, 15006, Spain

Location

Local Institution

Santander, 39008, Spain

Location

Local Institution

Seville, 41009, Spain

Location

Related Publications (3)

• 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.

  PMID: 31245054 DERIVED

• 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.

  PMID: 30522501 DERIVED

• 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.

  PMID: 28473423 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: June 17, 2013
• Primary Completion: July 14, 2015
• Study Completion: June 30, 2020
• Last Updated: April 5, 2022
• Results First Posted: August 2, 2017

Record last verified: 2022-03

Locations

CZ (3); ES (3); PE (3); US (17); FR (5); CL (3); GR (2); AR (6); BR (2); ME (7); DE (7); IT (4); CO (3); IL (4); CA (4); ZA (5); PL (4)