Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg

NCT00705367 | Completed Phase 1 Results

• 1 other identifier: IM101-217
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (7)

• Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs

  AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

  From Day 1 of double-blind period to 1st dose of long-term period

• Short-term Period: Number of Adverse Events (AEs) Related to Study Drug

  AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).

  From Day 1 of double-blind period to 1st dose of long-term period

• Short-term Period: MeanSystolic and Diastolic Blood Pressure

  Vital sign measurements are summarized without regard to position (sitting, standing, supine).

  Day 1 predose and postdose and Day 2

• Short-term Period: Mean Heart Rate

  Vital signs measurements are summarized without regard to position (sitting, standing, supine).

  Day 1 predose and postdose and Day 2

• Short-term Period: Mean Respirations Rate

  Vital sign measurements are summarized without regard to position (sitting, standing, supine).

  Day 1 predose and postdose and Day 2

• Short-term Period: Mean Temperature

  Vital sign measurements are summarized without regard to position (sitting, standing, supine).

  Day 1 predose and postdose and Day 2

• Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities

  Laboratory tests consisted of complete blood count, chemistry, and urinalysis.

  Screening and Days 1 and 2

Secondary Outcomes (7)

• Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs

  Days 15 to 56 days post last dose of the long-term period

• Minimum (Cmin) Plasma Concentration of Abatacept

  Days 15, 29, 85, 169, 253 and 337

• Maximum (Cmax) Plasma Concentration of Abatacept

  Postdosing Day 1

• Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests

  Days 15 to 56 days post last dose of the long-term period

• Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)

  Days 15 to 56 days post last dose of the long-term period

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Abatacept, 30 mg/kg

ACTIVE COMPARATOR

Drug: Abatacept

Abatacept, 10 mg/kg

OTHER

Open-label long-term extension phase

Drug: Abatacept

Interventions

Placebo DRUG

Infusion, Intravenous, single dose, Day 1

Placebo

Abatacept DRUG

Infusion, Intravenous, 30mg/kg, single dose, Day 1

Also known as: Orencia, BMS-188667

Abatacept, 30 mg/kg

Eligibility Criteria

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

You may qualify if:

• Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
• Stable renal disease
• No flaring of other organ systems in a minimum of the last 3 months

You may not qualify if:

• Unstable lupus nephritis and serum creatinine \>3 mg/dL
• Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
• Severe unstable, refractory, or progressive SLE
• History of cancer
• Participants at risk for tuberculosis
• Autoimmune disease other than SLE as main diagnosis
• Human immunodeficiency virus or herpes zoster infection
• Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Shanghai, Shanghai Municipality, 200001, China

Location

Related Publications (1)

• Liu MF, Wang CR, Lin LC, Wu CR. CTLA-4 gene polymorphism in promoter and exon-1 regions in Chinese patients with systemic lupus erythematosus. Lupus. 2001;10(9):647-9. doi: 10.1191/096120301682430249.

  PMID: 11678454 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: BMS 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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: July 1, 2011
• Last Updated: July 30, 2013
• Results First Posted: June 3, 2010

Record last verified: 2013-07

Locations

CN (1)