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Trial record 26 of 135 for:    "Connective Tissue Disease" | "Abatacept"

Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage

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ClinicalTrials.gov Identifier: NCT01333878
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : April 17, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Orrin M Troum, M.D. and Medical Associates

Tracking Information
First Submitted Date  ICMJE April 7, 2011
First Posted Date  ICMJE April 12, 2011
Last Update Posted Date April 17, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
Inhibition & progression of structural damage [ Time Frame: 6 months ]
Assess inhibition & progression of structural damage in MTX inadequate responders with moderate to severe active RA on SC Abatacept plus MTX, utilizing eMRI and X-ray at baseline, eMRI at Week 12, and eMRI and X-ray final assessment at week 24.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01333878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
Improvement in ESR-based DAS28 [ Time Frame: 6 months ]
Assess improvement in ESR-based DAS28, physician global assessment, and improvement in HAQ score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage
Official Title  ICMJE An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray
Brief Summary The hypothesis of this study is that subcutaneous Abatacept is effective in reducing synovial inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low field extremity MRI and X-ray.
Detailed Description

This is an open-label study of the efficacy of subcutaneous (SC) Abatacept to inhibit progression of structural joint damage in patients with active rheumatoid arthritis (RA) receiving MTX and have inadequate disease control (defined as an ESR based DAS28 ≥ 3.2 AND ≥ 6 swollen and ≥ 6 tender joints). The study consists of a screening period (Days -21 to -7), a baseline visit (Days -20 to -1), and a treatment Period (open label Abatacept 125 mg SC for 24 weeks). All the visits may occur at the indicated week +/- 2 days. The last efficacy assessments are to be conducted at Week 24 and subjects are to be contacted by telephone for a safety follow-up 2 months after the final study agent has been administered.

The maximum length of the study is 35 weeks, which includes the 2-week screening period, 1-week baseline period, 24-week open label treatment, and 8-week follow-up period. Eligible subjects are to continue their current MTX treatment regimen, a stable dose of at least 15mg/week, during the entire length of the study (24 weeks). At Day 0, patients who meet inclusion criteria, will be dosed from Day 0 to Week 24 with Abatacept 125 mg SC injection.

Subjects are to self-administer SC study agent at Weeks 5, 6, 7, 9, 10, 11, 13, 14, 15, 17, 18, 19, 21, 22, and 23 and are not required to return to the study site at these weeks. All other visits, SC study agent is to be administered while the subject is at the study site.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: Subcutaneous Abatacept
Subcutaneous Abatacept 125 mg once weekly for 6 months
Study Arms  ICMJE Experimental: Open-Label Subcutaneous Abatacept
Open-Label Subcutaneous Abatacept
Intervention: Biological: Subcutaneous Abatacept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2011)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects currently experiencing active moderate to severe RA according to the revised 1987 ACR criteria for the diagnosis of RA at screening. The ESR-based DAS 28 must be equal or greater than 3.2
  2. MTX inadequate responders with moderate to severe RA. Subjects currently receiving MTX for at least 12 weeks and who have received MTX at a stable dose (≥15mg/week) for at least 6 weeks prior to treatment (Day 0). They must be biologic drug naive
  3. All subjects must receive at least 5 mg oral folic acid weekly.
  4. At screening active RA as defined by ≥ 6 swollen joints and ≥ 6 tender joints with erythrocyte sedimentation rate (ESR) ≥ 28 mm/h.
  5. Subjects must be seropositive with documented rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti CCP) positivity. If a documented history of RF or anti CCP positivity is not available, RF and anti CCP titers will be obtained at screening
  6. MRI evidence of at least one joint with osteitis or erosion attributable to RA as determined by an MRI musculoskeletal radiologist. Any joint of the dominant hand or wrist can be considered with the exception of distal interphalangeal joints of the hands.
  7. If subjects are receiving an oral corticosteroid, the dose must be ≤10 mg/day prednisone (or equivalent) and stable for at least 28 days prior to treatment (Day 0).
  8. Subjects able and willing to give written informed consent and comply with the requirements of the study protocol. Informed consent must be obtained prior to any study-related procedures.

    A copy of the signed informed consent form must be given to the subject

  9. Subjects must be willing to self-inject or allow a caregiver to administer the subcutaneous injection

Exclusion Criteria:

  1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
  2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome). Prior history of or current inflammatory joint disease other than RA (gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis and psoriatic arthritis)
  3. Functional class IV as defined by the ACR Classification of Functional Status in RA
  4. Current treatment with any traditional DMARDs other than MTX within 4 weeks before the screening visit
  5. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
  6. Exposure to any Biologic Response Modifying Agent
  7. Intra Articular or parenteral corticosteroids within 6 weeks prior to screening
  8. Immunization with live vaccine within 3 months prior to enrollment and a need for a live vaccine during the study
  9. Subjects who have a metal device where the use of MRI is contraindicated (e.g.,any type of electronic, mechanical, or magnetic implant; cardiac pacemaker, aneurysm clip; implanted cardioverter defibrillator; or a cochlear implant). Subjects who have a potential ferromagnetic foreign body (metal shavings, metal slivers, other metal objects) for which they have sought medical attention
  10. Exclusionary laboratory: Serum creatinine >2 mg/dL, ALT or AST > 2.0 x ULN, total bilirubin > 2.0 x ULN, platelet count <100 x 109 /L, hemoglobin < 8.5 g/dL, WBC count < 1,000/mm3 , absolute neutrophil count < 1,000/ mm3, absolute lymphocyte count < 500/mm3, positive HBsAg or HCV antibody, or positive HIV test.
  11. Pregnant women or nursing mothers
  12. Females of child bearing potential who are not using reliable means of contraception
  13. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or GI disease
  14. Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel syndrome, where flares are commonly treated with corticosteroids
  15. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections such as atypical mycobacterial disease, hepatitis B and C, HIV, herpes zoster, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
  16. 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. A positive PPD skin test (≥5 mm) or positive QuantiFERON-TB Gold serum test without appropriate prophylaxis (at least 1 month of the planned local guidelines treatment regimen)
  17. Any malignancy except for skin cancer (basal cell or squamous cell) diagnosed within the previous 5 years
  18. History of alcohol, drug, or chemical abuse
  19. Neuropathies or other painful conditions that might interfere with pain evaluation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01333878
Other Study ID Numbers  ICMJE BMS IM101-281
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orrin M Troum, M.D. and Medical Associates
Study Sponsor  ICMJE Orrin M Troum, M.D. and Medical Associates
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Orrin M Troum, MD Orrin M. Troum, MD & Medical Associates
PRS Account Orrin M Troum, M.D. and Medical Associates
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP