Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

A Phase 3 study testing Adalimumab in people with Rheumatoid Arthritis, run by Abbott at 16 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 this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study. 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: 88 participants
Where: 16 sitesJapan
Study dates: Mar 2006to Nov 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

Completed Week 36 of Study M03-651 [NCT 00235872]
Wish to participate in self-injection study
Give written informed consent
Comply with protocol requirements

Who cannot join

Subject develops serious adverse events at time of eligibility confirmation
Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
The investigator considers the subject inappropriate for participation

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Japan16 sites

Study site
Aichi
Study site
Chiba
Study site
Fukuoka
Study site
Gunma
Study site
Hokkaido
Study site
Hyōgo
Study site
Ibaraki
Study site
Kanagawa
Study site
Miyagi
Study site
Nagano
Study site
Okayama
Study site
Osaka
Study site
Saitama
Study site
Shizuoka
Study site
Tokyo
Study site
Toyama

Other trials in Japan

About this study

Official title: A Non-Randomized, Open-Label, Roll-Over Study With Self Injection 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 Humira, ABT-D2E7
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection

Study groups in NCT00603993
Study group	Role	What they receive
Adalimumab	Experimental	Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT 00235872]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan 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 of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Number of responders with 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 physical disability via a health assessment questionnaire disability index(HAQ-DI), 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 (9)

Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit
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 ACR Criteria by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit
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's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (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 4 weeks 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 (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects 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 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 (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
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 Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the 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 of the ACR criteria by visit
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 ACR Criteria by Visit
Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)
Presence of Morning Stiffness by Visit
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
Measured: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.
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.

Mar 2006Nov 2006

First posted29 Jan 2008 (estimated)
Study startMar 2006
Primary completionNov 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: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00603993
Sponsor's protocol ID: M05-775
Status last verified: Jun 2011
First submitted: 10 Jan 2008
Last updated: 21 Jun 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 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT00603993
Acronym / sponsor ID: M05-775
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Abbott Japan Co.,Ltd, Eisai Co., Ltd.
Study start: Mar 2006
Primary completion: Nov 2006 (actual)
First posted: 29 Jan 2008 (estimated)
Results: Posted 4 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adalimumab	Experimental	Biological: AdalimumabAdalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT 00235872]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Completed Week 36 of Study M03-651 [NCT 00235872]
Wish to participate in self-injection study
Give written informed consent
Comply with protocol requirements

Key exclusion criteria (4 listed)

Subject develops serious adverse events at time of eligibility confirmation
Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
The investigator considers the subject inappropriate for participation

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: Humira, ABT-D2E740 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection	Biological	Adalimumab

Primary outcome

Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 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, 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 physical disability via a health assessment questionnaire disability index(HAQ-DI), 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 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 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 Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
Time frame: Every 4 weeks 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 (0 - 100 mm With 100 mm Being the Worst Assessment), 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 (0 - 100 mm With 100 mm Being the Worst Pain), 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 Disability Index of the Health Assessment Questionnaire (HAQ), 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 C-reactive Protein (CRP), 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)
Presence 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)
Duration (Minutes) of the Presence 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)

Results and safety

Results posted to the registry on 4 Feb 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 or 80 mg Every Other Week (Eow)	88	68

Primary outcome: Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 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. Unit: participants

Measure	Adalimumab 40 mg or 80 mg Every Other Week (Eow) n = 88
Week 0 ACR20	66
Week 0 ACR50	48
Week 0 ACR70	28
Week 4 ACR20	64
Week 4 ACR50	44
Week 4 ACR70	27
Week 8 ACR20	69
Week 8 ACR50	45

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 or 80 mg Every Other Week (Eow)	20 of 88 (22.7%)	84 of 88 (95.5%)	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 21 Jun 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, PhD study director

Abbott Japan

16 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 16 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 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 4 Feb 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 of at Least 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?

On the ClinicalTrials.gov record for NCT00603993.

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 21 Jun 2011.