PsoriasisPhase 2/3NCT00647400

Adalimumab in Adult Japanese Subjects With Psoriasis

A Phase 2/3 study testing adalimumab in people with Psoriasis, run by Abbott at 64 sites in Japan.

Completed

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

Trial summary

To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Psoriasis
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: 147 participants
Where: 64 sitesJapan
Study dates: Apr 2006to Apr 2010
Phase: Phase 2/3
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

Participants who completed Study M04-688 (NCT00338754)

Who cannot join

Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Trial locations and contacts

64 sites in 1 country.

City, postcode or hospital

64 sites in 1 country

Japan64 sites

Site Ref # / Investigator 5491
Bunkyō City
Site Ref # / Investigator 5429
Chiyoda-ku
Site Ref # / Investigator 5464
Fukuoka
Site Ref # / Investigator 5477
Fukuoka
Site Ref # / Investigator 5492
Fukuoka
Site Ref # / Investigator 5504
Fukuoka
Site Ref # / Investigator 5400
Fukushima
Site Ref # / Investigator 5406
Fukushima
Site Ref # / Investigator 5407
Fukushima
Site Ref # / Investigator 5437
Fukushima
Site Ref # / Investigator 5401
Gifu
Site Ref # / Investigator 5434
Gifu
Site Ref # / Investigator 5408
Hamamatsu
Site Ref # / Investigator 5495
Hiroshima
Site Ref # / Investigator 5391
Hokkaido
Site Ref # / Investigator 5402
Ishikawa
Site Ref # / Investigator 5462
Kagoshima
Site Ref # / Investigator 5476
Kagoshima
Site Ref # / Investigator 5435
Kanagawa
Site Ref # / Investigator 5432
Kawachi-gun
Site Ref # / Investigator 5440
Kawasaki
Site Ref # / Investigator 5499
Kyoto
Site Ref # / Investigator 5503
Kyoto
Site Ref # / Investigator 5411
Minatoku
Site Ref # / Investigator 5404
Mitaka
Site Ref # / Investigator 5417
Miyagi
Site Ref # / Investigator 5463
Nagasaki
Site Ref # / Investigator 5427
Nagoya
Site Ref # / Investigator 5465
Nankoku
Site Ref # / Investigator 5493
Nankoku
Site Ref # / Investigator 5482
Nishinomiya
Site Ref # / Investigator 5395
Numakunai
Site Ref # / Investigator 5496
Okayama
Site Ref # / Investigator 5441
Osaka
Site Ref # / Investigator 5467
Osaka
Site Ref # / Investigator 5480
Osaka
Site Ref # / Investigator 5483
Osaka
Site Ref # / Investigator 5498
Osaka
Site Ref # / Investigator 5388
Sapporo
Site Ref # / Investigator 5396
Sapporo
Site Ref # / Investigator 5399
Sapporo
Site Ref # / Investigator 5414
Shinjuku-ku
Site Ref # / Investigator 5433
Shizuoka
Site Ref # / Investigator 5466
Suita
Site Ref # / Investigator 5497
Suita
Site Ref # / Investigator 5505
Suita
Site Ref # / Investigator 5431
tabashi City
Site Ref # / Investigator 5481
Tokushima
Site Ref # / Investigator 5506
Tokushima
Site Ref # / Investigator 6918
Tokushima
Site Ref # / Investigator 5405
Tokyo
Site Ref # / Investigator 5409
Tokyo
Site Ref # / Investigator 5410
Tokyo
Site Ref # / Investigator 5412
Tokyo
Site Ref # / Investigator 5413
Tokyo
Site Ref # / Investigator 5430
Tokyo
Site Ref # / Investigator 6553
Tokyo
Site Ref # / Investigator 5468
Tsu
Site Ref # / Investigator 5475
Ube
Site Ref # / Investigator 5415
Urayasu
Site Ref # / Investigator 5438
Urayasu
Site Ref # / Investigator 5416
Yamagata
Site Ref # / Investigator 5403
Yokohama
Site Ref # / Investigator 5428
Yokohama

Other trials in Japan

About this study

Official title: A Multicenter Open-Label Continuation Study of the Long-term Safety and Efficacy of Adalimumab (D2E7) in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis

Read the detailed description

This was a continuation trial of adalimumab in participants with moderate to severe chronic plaque psoriasis who had completed Study M04-688 (NCT00338754), a 24-week, double-blind, placebo-controlled study. This study was an open-label extension study that continued until the approval of adalimumab for the treatment of psoriasis in Japan.

During Study M04-688 (NCT00338754), participants received 24 weeks of treatment with adalimumab 40 mg every other week (eow) with or without a loading dose, adalimumab 80 mg eow, or placebo.

At the start of this study, participants who had received adalimumab 40 mg eow or adalimumab 80 mg eow in Study M04-688 (NCT00338754) continued on the same treatment regimen. Participants who had received placebo during Study M04-688 (NCT00338754) were re-randomized at the start of this study to receive adalimumab 40 mg eow or adalimumab 80 mg eow.

Participants in the adalimumab 40 mg eow treatment group who failed to achieve a PASI50 response (>= 50% reduction in the Psoriasis Area and Severity Index score from Baseline of Study M04-688 [NCT00338754]) at or anytime after Week 12 of this study were given the option to increase their dose to adalimumab 80 mg eow. Once the dose was escalated, there was no option to de-escalate dosing back to 40 mg eow. Participants who failed to achieve PASI50 responses while receiving adalimumab 80 mg eow may have been discontinued from the study after evaluating the risk/benefit of further treatment with adalimumab.

At Week 28 of this study, it was mandatory for all participants who started the study in the adalimumab 80 mg eow treatment group (i.e., not including the dose escalators described above) to reduce their dose to adalimumab 40 mg eow, regardless of their response status. Following this mandatory dose reduction, if these participants failed to achieve or maintain PASI50 response, they were permitted to escalate their dose to adalimumab 80 mg eow. There was no option to de-escalate dosing back to 40 mg eow following dose escalation.

Data in this clinical trial results disclosure are analyzed as observed according to treatment received at the start of this study (i.e., adalimumab 40 mg eow or adalimumab 80 mg eow) regardless of subsequent dose escalation. Data are summarized according to participants' cumulative exposure to adalimumab in Study M04-688 (NCT00338754) and this study.

Conditions: Psoriasis
Being tested: adalimumab
Keywords: Psoriasis
Medical subject headings: Psoriasis

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
Adalimumab 40 mg every other week, subcutaneous
adalimumabBiological
Also called ABT-D2E7, Humira
Adalimumab 80 mg every other week, subcutaneous

Study groups in NCT00647400
Study group	Role	What they receive
Adalimumab 40 mg every other week	Experimental	Not described Receives: Biological: adalimumab
Adalimumab 80 mg every other week	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 Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Measured: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab

Secondary outcomes (2)

Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Measured: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Measured: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Apr 2010

First posted31 Mar 2008 (estimated)
Study startApr 2006
Primary completionSep 2007
Study completionApr 2010

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 PsoriasisStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00647400
Sponsor's protocol ID: M04-702
Status last verified: Apr 2011
First submitted: 27 Mar 2008
Last updated: 8 Apr 2011
Results posted: Yes, on ClinicalTrials.gov

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

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Open-Label Continuation Study of the Long-term Safety and Efficacy of Adalimumab (D2E7) in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
ClinicalTrials.gov ID: NCT00647400
Acronym / sponsor ID: M04-702
Conditions: Psoriasis
Keywords: Psoriasis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Abbott Japan Co.,Ltd, Eisai Co., Ltd.
Study start: Apr 2006
Primary completion: Sep 2007 (actual)
Study completion: Apr 2010 (actual)
First posted: 31 Mar 2008 (estimated)
Results: Posted 11 Jan 2010

Clinical summary

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

To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis

Detailed description

During Study M04-688 (NCT00338754), participants received 24 weeks of treatment with adalimumab 40 mg every other week (eow) with or without a loading dose, adalimumab 80 mg eow, or placebo.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Adalimumab 40 mg every other week	Experimental	Biological: adalimumab
Adalimumab 80 mg every other week	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 (1 listed)

Participants who completed Study M04-688 (NCT00338754)

Key exclusion criteria (1 listed)

Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study

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, HumiraAdalimumab 40 mg every other week, subcutaneous	Biological	Adalimumab 40 mg every other week
adalimumabAlso: ABT-D2E7, HumiraAdalimumab 80 mg every other week, subcutaneous	Biological	Adalimumab 80 mg every other week

Primary outcome

Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
Time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).

2 secondary outcomes

Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
Time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
Time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab

Results and safety

Results posted to the registry on 11 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 Every Other Week	89	67
Adalimumab 80 mg Every Other Week	58	45

Primary outcome: Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)

Time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab. Number. Unit: Participants

Measure	Adalimumab 40 mg Every Other Week n = 89	Adalimumab 80 mg Every Other Week n = 58
12 weeks (N = 89 [40 mg eow] and 57 [80 mg eow])	78	54
24 weeks (N = 88 [40 mg eow] and 56 [80 mg eow])	80	55
36 weeks (N = 87 [40 mg eow] and 54 [80 mg eow])	79	52
52 weeks (N = 85 [40 mg eow] and 52 [80 mg eow])	80	51
76 weeks (N = 80 [40 mg eow] and 52 [80 mg eow])	76	52
100 weeks (N = 78 [40 mg eow] and 52 [80 mg eow])	75	49
160 weeks (N = 71 [40 mg eow] and 47 [80 mg eow])	71	47
208 weeks (N = 29 [40 mg eow] and 14 [80 mg eow])	29	14

Population analysed: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are reported starting from the first dose of adalimumab (in Study M04-688 [NCT00338754] or in Study M04-702) up to 70 days after the last dose of adalimumab.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab 40 mg Every Other Week	19 of 89 (21.3%)	88 of 89 (98.9%)	Not reported
Adalimumab 80 mg Every Other Week	11 of 58 (19%)	58 of 58 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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.

Kazuko Kobayashi study director

Abbott

64 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 Psoriasis, run by Abbott at 64 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 8 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 64 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 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?

Yes. Results are posted in the registry (first posted 11 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 Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) (time frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab). 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 NCT00647400.

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 8 Apr 2011.