Phase III Study in China - Tolerance - Full Text View

Purpose

The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)

Condition	Intervention	Phase
Immunosuppression for Disease, NOS	Drug: Placebo Drug: Abatacept	Phase III

ChemIDplus related topics:

Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Number and type of adverse events experienced including serious or unexpected peri-infusional adverse events [ Time Frame: during the double-blind single dose phase of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Summary of adverse events [ Time Frame: during the long-term extension ] [ Designated as safety issue: Yes ]
Pharmacokinetic analysis (Cmin and Cmax) [ Time Frame: on days 1, 15, 29, 85, 169, 253 and Day 337 or Discontinuation ] [ Designated as safety issue: No ]
Immunogenicity determination (anti-abatacept antibodies) [ Time Frame: on Day 1 and then every 6 months on study ] [ Designated as safety issue: No ]

Estimated Enrollment:	9
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Placebo Comparator	Drug: Placebo Infusion, Intravenous, 0mg, single dose, 24 hours
A2: Active Comparator	Drug: Abatacept Infusion, Intravenous, 30mg/kg, single dose, 24 hours

Eligibility

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

Criteria

Inclusion Criteria:

Men and women, at least 18 years of age diagnosed with SLE and with lupus nephritis currently stable for the last 3 months without change in their treatment for lupus nephritis
Stable renal disease
No flaring of other organ systems in at least the last 3 months

Exclusion Criteria:

Unstable Lupus Nephritis and serum creatinine >3 mg/dL
Progressive renal failure, end stage renal disease, renal transplant, requiring continuous dialysis
Severe unstable, refractory or progressive SLE
History of cancer
Subjects at risk for tuberculosis
Autoimmune disease other than SLE as main diagnosis
HIV or Herpes zoster
Hepatitis-B surface antigen-positive or Hepatitis C antibody-positive subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705367

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.

Locations


China
	Local Institution	Recruiting
	Shanghai, China, 200001
	Contact: Site 001

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-217
First Received:	June 24, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00705367
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Abatacept

Lupus Nephritis

Nephritis

Additional relevant MeSH terms:

Immunologic Factors

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00705367