A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

NCT00345748 | Completed Phase 2

• 1 other identifier: IM101-071
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 38

Brief Summary

The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Efficacy will be evaluated using the American College of Rheumatology response rate or ACR 20. This means the respective proportion of patients reaching an improvement of at least 20% of the ACR composite index from baseline.

  at 6 months

Secondary Outcomes (2)

• ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity

  at 6 months

• Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)

  at 6 months

Study Arms (3)

Abatacept 2 mg/kg

ACTIVE COMPARATOR

Drug: Abatacept

Abatacept 10 mg/kg

ACTIVE COMPARATOR

Drug: Abatacept

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Abatacept DRUG

Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Also known as: Orencia

Abatacept 10 mg/kg; Abatacept 2 mg/kg

Placebo DRUG

Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization

You may not qualify if:

• no current infection or other evolutive or uncontrolled disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (38)

Local Institution

Nagoya, Aichi-ken, 460-0001, Japan

Location

Local Institution

Nagoya, Aichi-ken, 466-8550, Japan

Location

Local Institution

Goshogawara-Shi, Aomori, 037-0053, Japan

Location

Local Institution

Chiba, Chiba, Japan

Location

Local Institution

Fukui-shi, Fukui, 910-0041, Japan

Location

Local Institution

Fukui-shi, Fukui, 910-0067, Japan

Location

Local Institution

Fukuoka, Fukuoka, 810-0065, Japan

Location

Local Institution

Fukuoka, Fukuoka, 812-0025, Japan

Location

Local Institution

Kitakyushu-Shi, Fukuoka, 807-8555, Japan

Location

Local Institution

Higashi-Hiroshima-Shi, Hiroshima, 739-0002, Japan

Location

Local Institution

Sapporo, Hokkaido, 060-0001, Japan

Location

Local Institution

Sapporo, Hokkaido, 060-8604, Japan

Location

Local Institution

Sapporo, Hokkaido, 060-8648, Japan

Location

Local Institution

Kanzaki-Gun, Hyōgo, 679-2414, Japan

Location

Local Institution

Kato-Gun, Hyōgo, 673-1462, Japan

Location

Local Institution

Hitachi-Shi, Ibaraki, 316-0035, Japan

Location

Local Institution

Tsukuba, Ibaraki, 305-0005, Japan

Location

Local Institution

Sagamihara-Shi, Kanagawa, 228-8522, Japan

Location

Local Institution

Sendai, Miyagi, 981-0911, Japan

Location

Local Institution

Sendai, Miyagi, 982-0032, Japan

Location

Local Institution

Sendai, Miyagi, Japan

Location

Local Institution

Nagano, Nagano, 380-8582, Japan

Location

Local Institution

Tsukubo-Gun, Okayama-ken, 701-0304, Japan

Location

Local Institution

Kawachinagano-Shi, Osaka, 86-0008, Japan

Location

Local Institution

Ureshino-Shi, Saga-ken, 843-0301, Japan

Location

Local Institution

Iruma-Gun, Saitama, 350-0495, Japan

Location

Local Institution

Kawagoe-Shi, Saitama, 350-8550, Japan

Location

Local Institution

Kitamoto-Shi, Saitama, 364-0026, Japan

Location

Local Institution

Hamamatsu, Shizuoka, 430-0906, Japan

Location

Local Institution

Kawachigun, Tochigi, 329-1104, Japan

Location

Local Institution

Tochigi, Tochigi, 329-0498, Japan

Location

Local Institution

Arakawa-Ku, Tokyo, 116-0011, Japan

Location

Local Institution

Bunkyo-Ku, Tokyo, 113-0022, Japan

Location

Local Institution

Bunkyo-Ku, Tokyo, 113-8519, Japan

Location

Local Institution

Setagaya-Ku, Tokyo, 155-0032, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 162-0054, Japan

Location

Local Institution

Takaoka-Shi, Toyama, 933-8525, Japan

Location

Local Institution

Chiba, 260-0801, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; 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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 28, 2006
• Study Start: June 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 25, 2011

Record last verified: 2011-04

Locations

JP (38)