ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

This study is currently recruiting participants.
Study NCT00430677.   Last updated on November 19, 2008.   Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Official Title  A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)
Brief Summary

The purpose of this clinical research study is to learn if abatacept treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and steroids as part of this study will control the nephritis despite a protocol-defined steroid taper; the endpoint is a "complete renal response", a composite including normalization of renal function (or stable normal function if function was normal at study entry) plus disappearance of protein and cells/casts from the urinary sediment. The safety of this treatment will also be studied

Detailed Description
Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Renal response [ Time Frame: Time to occurrence ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Proportion of subjects achieving renal response [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
Proportion of subjects maintaining renal response [ Time Frame: for at least 3 months ] [ Designated as safety issue: No ]
Proportion of subjects/time to occurrence of renal improvement (partial response) [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
Change in renal function [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
SLE disease activity/ACR Damage Index Assessment [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
Score on quality of life scales [ Time Frame: within 1 year ] [ Designated as safety issue: No ]
Safety of abatacept [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Condition  Systemic Lupus Erythematosus
Intervention  Drug: steroids (prednisone or prednisolone) + MMF
Drug: abatacept
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  303
Start Date  June 2007
Completion Date June 2010
Eligibility Criteria 

Inclusion Criteria:

  • SLE as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
  • Renal Biopsy within 12 months of randomization (Day 1) indicating active proliferative lupus glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-g (C)] or WHO 1982 Classification Class III or IV (excluding Class IIIc, IVd).
  • Active renal disease at the screening visit, as defined by: urinary protein/creatinine ratio ≥0.5 AND an active urinary sediment as defined by at least one of the following 3 criteria: i) >5 RBC/hpf OR ii) >5 WBC/hpf (with no evidence of a urinary tract infection) OR iii) cylindruria AND
  • A Stable serum creatine ≤3 mg/dL

Exclusion Criteria:

  • Subjects with a rise in serum creatine of ≥1 mg/dL within 1 month prior to the screening visit
  • Subjects with drug-induced SLE, as opposed to idiopathic SLE
  • Subjects with severe, unstable and/or progressive CNS lupus
  • Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; RA, MS)
  • Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
  • Subjects who have received treatment with rituximab < 6 months prior to the screening visit
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:         Clinical.Trials@bms.com    
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.            
Location Countries  United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   France,   Hong Kong,   India,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   South Africa,   Taiwan,   Turkey,   United Kingdom
Administrative Information Fields
NCT ID  NCT00430677
Organization ID IM101-075
Secondary IDs ††
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Study Director:     Bristol-Myers Squibb     Bristol-Myers Squibb    
Information Provided By Bristol-Myers Squibb
Verification Date November 2008
First Received Date  February 1, 2007
Last Updated Date November 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers