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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01860976
First received: May 21, 2013
Last updated: August 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Psoriatic Arthritis
Drug: Abatacept
Drug: Placebo matching with Abatacept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of ACR20 responders [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
    ACR20=20% American College of Rheumatology response


Secondary Outcome Measures:
  • Proportion of Health Assessment Questionnaire (HAQ) responders (a reduction of at least 0.35 from baseline) [ Time Frame: Baseline (Day 1) and Day 169 ] [ Designated as safety issue: No ]
  • Proportion of ACR20 responders in the TNFi naive subpopulation [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
    TNFi=Tumor necrosis factor-α inhibitors

  • Proportion of ACR20 responders in the TNFi exposed subpopulation [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

    PsA=Psoriatic arthritis

    SHS=Sharp/van der Heidje Score



Other Outcome Measures:
  • Proportion of subjects achieving a PASI50 (achieving at least 50% improvement from baseline in PASI) in subjects with baseline BSA ≥3% [ Time Frame: Baseline (Day 1) and Day 169 ] [ Designated as safety issue: No ]

    PASI=Psoriasis Area and Severity Index

    BSA=Body Surface Area


  • Proportion of ACR50 responders [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • Proportion of ACR70 responders [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • Mean change from baseline in physical (PCS) and mental functions (MCS) of SF-36 [ Time Frame: Baseline (Day 1) and Day 169 ] [ Designated as safety issue: No ]

    PCS=Physical Component Score

    MCS=Mental Component Score

    SF-36=Short Form 36


  • Proportion of subjects with at least one positive immunogenicity response [ Time Frame: Up to Day 169 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with adverse events (AEs), deaths, serious AEs, and AEs leading to discontinuation and proportion of laboratory marked abnormalities [ Time Frame: Up to Day 169 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: June 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: 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
Drug: Abatacept
Other Name: Orencia
Experimental: Arm 2: Placebo matching with Abatacept
Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind
Drug: Placebo matching with Abatacept

Detailed Description:

ASTRAEA=Active PSoriaTic ARthritis RAndomizEd TriAl

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Prior use of Apremilast, Ustekinumab or Briakinumab
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860976

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 83 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01860976     History of Changes
Other Study ID Numbers: IM101-332, 2012-002798-80
Study First Received: May 21, 2013
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014