Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

A Phase 2 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 7 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 7 sitesJapan
Study dates: Jun 2003to Oct 2004
Phase: Phase 2
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 in the prior adalimumab study
Body weight less than 100 kg.
Subject's who wished to continue the study drug administration
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.

Who cannot join

A subject who experienced any of the following during the prior adalimumab sc dosing study:
Advanced or poorly controlled diabetes
Any poorly controlled medical condition
Intra-articular, intramuscular or iv administration of corticosteroids
Joint surgery.
A subject who has been prescribed excluded medications during previous adalimumab study.

Show all 9Show fewer

History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

Study site
Fukuoka, Prefecture
Study site
Hiroshima, Prefecture
Study site
Ibaraki, Prefecture
Study site
Nagasaki, Prefecture
Study site
Osaka, Prefecture
Study site
Saitama, Prefecture
Study site
Tokyo, Metropolis

Other trials in Japan

About this study

Official title: Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis

The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult 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 every other week (eow), subcutaneous (sc)

Study groups in NCT00235833
Study group	Role	What they receive
Adalimumab 40 mg 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 Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, 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 [HAQ], and [5] C-reactive protein [CRP]) at each visit
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

Secondary outcomes (9)

Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 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 the of ACR criteria, by visit
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (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 [HAQ], and [5] C-reactive protein (CRP)
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter
Number of Subjects With Morning Stiffness at Each Visit
The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).
Measured: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to 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.

Jun 2003Oct 2004

First posted12 Oct 2005 (estimated)
Study startJun 2003
Primary completionOct 2004

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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00235833
Sponsor's protocol ID: M02-564
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

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: Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT00235833
Acronym / sponsor ID: M02-564
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Abbott Japan Co.,Ltd, Eisai Co., Ltd.
Study start: Jun 2003
Primary completion: Oct 2004 (actual)
First posted: 12 Oct 2005 (estimated)
Results: Posted 29 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, tolerability, and efficacy of repeated administration of adalimumab in adult 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 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 (4 listed)

Participation in the prior adalimumab study
Body weight less than 100 kg.
Subject's who wished to continue the study drug administration
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.

Key exclusion criteria (9 listed)

A subject who experienced any of the following during the prior adalimumab sc dosing study:
A subject who has been prescribed excluded medications during previous adalimumab study.
History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.

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 every other week (eow), subcutaneous (sc)	Biological	Adalimumab 40 mg eow

Primary outcome

Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, 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 [HAQ], and [5] C-reactive protein [CRP]) at each visit

9 secondary outcomes

Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter
Number of Subjects With Morning Stiffness at Each Visit
Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

Results and safety

Results posted to the registry on 29 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab 40 mg Eow	25	9

Primary outcome: Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)

Time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value). Number. Unit: participants

Measure	Adalimumab 40 mg Eow n = 25
Week 0 ACR20	12
Week 0 ACR50	7
Week 0 ACR70	5
Week 6 ACR20	15
Week 6 ACR50	12
Week 6 ACR70	5
Week 12 ACR20	16
Week 12 ACR50	11

Population analysed: Analysis was based on observed data.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab 40 mg Eow	10 of 25 (40%)	25 of 25 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to the small population, statistical tests were not performed.

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.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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

7 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 adalimumab in people with Rheumatoid Arthritis, run by Abbott at 7 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 9 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 7 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 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?

Yes. Results are posted in the registry (first posted 29 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 Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) (time frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to 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?

On the ClinicalTrials.gov record for NCT00235833.

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.