Rheumatoid ArthritisPhase 3NCT00235872
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
A Phase 3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 25 sites in Japan.
Trial summary
The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis. 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?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 25 sitesJapan
- Study dates
- Aug 2004to Jul 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
- Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
- Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.
Who cannot join
- A subject who experienced any of the following during prior study:
- Advanced or poorly controlled diabetes
- Joint surgery (joint evaluated in this study)
- A subject who has been prescribed excluded medications during prior study.
- History of following during prior study:
- Clinically significant drug or alcohol abuse
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- Intravenous (iv) drug abuse
- Active infection with listeria or tuberculosis (TB)
- Lymphoma, leukemia
- And, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin.
- A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Study site
Aichi, Prefecture
Study site
Chiba, Prefecture
Study site
Ehime, Prefecture
Study site
Fukui, Prefecture
Study site
Fukuoka, Prefecture
Study site
Gunma, Prefecture
Study site
Hokkaido, Prefecture
Study site
Hyōgo, Prefecture
Study site
Ibaraki, Prefecture
Study site
Ishikawa, Prefecture
Study site
Kagoshima, Prefecture
Study site
Kanagawa, Prefecture
Study site
Kyoto, Prefecture
Study site
Miyagi, Prefecture
Study site
Nagano, Prefecture
Study site
Nagasaki, Prefecture
Study site
Niigata, Prefecture
Study site
Okayama, Prefecture
Study site
Osaka, Prefecture
Study site
Saitama, Prefecture
Study site
Shizuoka, Prefecture
Study site
Tochigi, Prefecture
Study site
Tokushima, Prefecture
Study site
Tokyo, Metropolis
Study site
Toyama, Prefecture
About this study
Official title: Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis
The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab
- Keywords
- Rheumatoid arthritis
- 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
40 mg eow, sc
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab 40 mg every other week (eow) | Experimental | Not described Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Secondary outcomes (11)
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Presence of Morning Stiffness
The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Presence of Rheumatoid Factor (RF)
The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Japan Co.,Ltd, Eisai Co., Ltd.
- Investigators
- Shigeki Hashimoto, Ph.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235872
- Sponsor's protocol ID
- M03-651
- Status last verified
- Apr 2011
- First submitted
- 7 Oct 2005
- Last updated
- 11 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Continuous Administration Study With Adalimumab (D2E7) in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00235872
- Acronym / sponsor ID
- M03-651
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Japan Co.,Ltd, Eisai Co., Ltd.
- Study start
- Aug 2004
- Primary completion
- Jul 2006 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 13 Jan 2010
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 the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab 40 mg every other week (eow) | Experimental | Biological: adalimumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation and completion until Week 24 of the prior adalimumab dose-ranging study.
- Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.
- Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior adalimumab study, if capable of pregnancy.
Key exclusion criteria (11 listed)
- A subject who experienced any of the following during prior study:
- A subject who has been prescribed excluded medications during prior study.
- History of following during prior study:
- A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
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, Humira40 mg eow, sc | Biological | Adalimumab 40 mg every other week (eow) |
Primary outcome
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
11 secondary outcomes
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Presence of Morning Stiffness
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Presence of Rheumatoid Factor (RF)
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 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 3 inclusion and 11 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 11 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 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. 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 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?
Yes. Results are posted in the registry (first posted 13 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) (time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)). 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 11 Apr 2011.