Rheumatoid ArthritisPhase 2/3NCT00647491
A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
A Phase 2/3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 25 sites in Japan.
Trial summary
The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA 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?
- adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 25 sitesJapan
- Study dates
- Feb 2004to Aug 2005
- Phase
- Phase 2/3
- 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
- Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
- Subjects must have failed prior treatment with one or more DMARDs.
- A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
- Body weight less than or equal to 100 kg
Who cannot join
- A history of, or current, acute inflammatory joint disease of different origin from RA.
- Prior treatment with any TNF antagonist, including adalimumab.
- Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
- Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Study site
Aichi
Study site
Chiba
Study site
Ehime
Study site
Fukui
Study site
Fukuoka
Study site
Gunma
Study site
Hokkaido
Study site
Hyōgo
Study site
Ibaraki
Study site
Ishikawa
Study site
Kagoshima
Study site
Kanagawa
Study site
Kyoto
Study site
Miyagi
Study site
Nagano
Study site
Nagasaki
Study site
Niigata
Study site
Okayama
Study site
Osaka
Study site
Saitama
Study site
Shizuoka
Study site
Tochigi
Study site
Tokushima
Study site
Tokyo
Study site
Toyama
About this study
The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab, 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.
adalimumabBiological
Also called ABT-D2E7, Humira
20 mg sc eow
adalimumabBiological
Also called ABT-D2E7, Humira
40 mg sc eow
adalimumabBiological
Also called ABT-D2E7, Humira
80 mg sc eow
placeboBiological
placebo sc eow
| Study group | Role | What they receive |
|---|---|---|
| 20 mg | Experimental | 20 mg adalimumab eow Receives: Biological: adalimumab |
| 40 mg | Experimental | 40 mg adalimumab eow Receives: Biological: adalimumab |
| 80 mg | Experimental | 80 mg adalimumab eow Receives: Biological: adalimumab |
| Placebo | Placebo comparator | Placebo eow Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20
Measured: Week 24
Secondary outcomes (3)
ACR20
Measured: Week12
ACR50
Measured: Weeks 12 and 24
ACR70
Measured: Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startFeb 2004
- Primary completionJun 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Investigators
- Shigeki Hashimoto, Ph.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647491
- Sponsor's protocol ID
- M02-575
- Status last verified
- Mar 2008
- First submitted
- 27 Mar 2008
- Last updated
- 31 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PubMed 27338778
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00647491
- Acronym / sponsor ID
- M02-575
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Study start
- Feb 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 31 Mar 2008 (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 primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 mg | Experimental | Biological: adalimumab20 mg adalimumab eow |
| 40 mg | Experimental | Biological: adalimumab40 mg adalimumab eow |
| 80 mg | Experimental | Biological: adalimumab80 mg adalimumab eow |
| Placebo | Placebo comparator | Biological: placeboPlacebo eow |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
- Subjects must have failed prior treatment with one or more DMARDs.
- A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
- Body weight less than or equal to 100 kg
Key exclusion criteria (4 listed)
- A history of, or current, acute inflammatory joint disease of different origin from RA.
- Prior treatment with any TNF antagonist, including adalimumab.
- Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
- Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
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 |
|---|---|---|
| adalimumabAlso: ABT-D2E7, Humira20 mg sc eow | Biological | 20 mg |
| adalimumabAlso: ABT-D2E7, Humira40 mg sc eow | Biological | 40 mg |
| adalimumabAlso: ABT-D2E7, Humira80 mg sc eow | Biological | 80 mg |
| placeboplacebo sc eow | Biological | Placebo |
Primary outcome
ACR20
Time frame: Week 24
3 secondary outcomes
ACR20
Time frame: Week12
ACR50
Time frame: Weeks 12 and 24
ACR70
Time frame: Weeks 12 and 24
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 31 Mar 2008.
- Derived from this study: PubMed 27338778Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
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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.
Shigeki Hashimoto, Ph.D. study director
Abbott
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 25 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 4 inclusion and 4 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 31 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
ACR20 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647491, which also lists 1 linked publication.
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 31 Mar 2008.