Rheumatoid ArthritisPhase 2NCT00345748
A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
A Phase 2 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 38 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 38 sitesJapan
- Study dates
- Jun 2006to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization
Who cannot join
- no current infection or other evolutive or uncontrolled disease
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Japan38 sites
Local Institution
Arakawa-Ku, Tokyo, 116-0011
Local Institution
Bunkyo-Ku, Tokyo, 113-0022
Local Institution
Bunkyo-Ku, Tokyo, 113-8519
Local Institution
Chiba, Chiba
Local Institution
Chiba, 260-0801
Local Institution
Fukui-shi, Fukui, 910-0041
Local Institution
Fukui-shi, Fukui, 910-0067
Local Institution
Fukuoka, Fukuoka, 810-0065
Local Institution
Fukuoka, Fukuoka, 812-0025
Local Institution
Goshogawara-Shi, Aomori, 037-0053
Local Institution
Hamamatsu, Shizuoka, 430-0906
Local Institution
Higashi-Hiroshima-Shi, Hiroshima, 739-0002
Local Institution
Hitachi-Shi, Ibaraki, 316-0035
Local Institution
Iruma-Gun, Saitama, 350-0495
Local Institution
Kanzaki-Gun, Hyōgo, 679-2414
Local Institution
Kato-Gun, Hyōgo, 673-1462
Local Institution
Kawachigun, Tochigi, 329-1104
Local Institution
Kawachinagano-Shi, Osaka, 86-0008
Local Institution
Kawagoe-Shi, Saitama, 350-8550
Local Institution
Kitakyushu-Shi, Fukuoka, 807-8555
Local Institution
Kitamoto-Shi, Saitama, 364-0026
Local Institution
Nagano, Nagano, 380-8582
Local Institution
Nagoya, Aichi-ken, 460-0001
Local Institution
Nagoya, Aichi-ken, 466-8550
Local Institution
Sagamihara-Shi, Kanagawa, 228-8522
Local Institution
Sapporo, Hokkaido, 060-0001
Local Institution
Sapporo, Hokkaido, 060-8604
Local Institution
Sapporo, Hokkaido, 060-8648
Local Institution
Sendai, Miyagi, 981-0911
Local Institution
Sendai, Miyagi, 982-0032
Local Institution
Sendai, Miyagi
Local Institution
Setagaya-Ku, Tokyo, 155-0032
Local Institution
Shinjuku-Ku, Tokyo, 162-0054
Local Institution
Takaoka-Shi, Toyama, 933-8525
Local Institution
Tochigi, Tochigi, 329-0498
Local Institution
Tsukuba, Ibaraki, 305-0005
Local Institution
Tsukubo-Gun, Okayama-ken, 701-0304
Local Institution
Ureshino-Shi, Saga-ken, 843-0301
About this study
Official title: A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
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
- Being tested
- Abatacept, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
PlaceboDrug
Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Abatacept 2 mg/kg | Active comparator | Not described Receives: Drug: Abatacept |
| Abatacept 10 mg/kg | Active comparator | Not described Receives: Drug: Abatacept |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345748
- Sponsor's protocol ID
- IM101-071
- Status last verified
- Apr 2011
- First submitted
- 23 Jun 2006
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
- ClinicalTrials.gov ID
- NCT00345748
- Acronym / sponsor ID
- IM101-071
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abatacept 2 mg/kg | Active comparator | Drug: Abatacept |
| Abatacept 10 mg/kg | Active comparator | Drug: Abatacept |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization
Key exclusion criteria (1 listed)
- no current infection or other evolutive or uncontrolled disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: OrenciaInjection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks | Drug | Abatacept 10 mg/kg, Abatacept 2 mg/kg |
| PlaceboInjectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks | Drug | Placebo |
Primary outcome
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.
Time frame: at 6 months
2 secondary outcomes
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
Time frame: 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)
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 38 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2011.