A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

A Phase 2/3 study testing adalimumab in people with Crohn's Disease, run by Abbott at 18 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 demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease. Read more about this study

Who is it for?: Ages 15 to 75 years
Conditions the study is for: Crohn's Disease
What is being tested?: adalimumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 18 sitesJapan
Study dates: Feb 2007to Dec 2007
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 15 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450
If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy

Who cannot join

Ulcerative colitis or indeterminate colitis
History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
Body weight is below 30 kg
Surgical bowel resections within the past 6 months
Females who are pregnant or breast-feeding or considering becoming pregnant during the study

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Japan18 sites

Study site
Aichi
Study site
Chiba
Study site
Ehime
Study site
Fukuoka
Study site
Hiroshima
Study site
Hokkaido
Study site
Hyōgo
Study site
Kagawa
Study site
Kanagawa
Study site
Kochi
Study site
Kyoto
Study site
Miyagi
Study site
Okayama
Study site
Okinawa
Study site
Osaka
Study site
Shiga
Study site
Shizuoka
Study site
Tokyo

Other trials in Japan

About this study

Official title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

Conditions: Crohn's Disease
Being tested: adalimumab, placebo
Medical subject headings: Crohn Disease

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
160 mg at Week 0, 80 mg at Week 2
adalimumabBiological
Also called ABT-D2E7, Humira
80 mg at Week 0, 40 mg at Week 2
placeboBiological
Placebo at Week 0 and Week 2

Study groups in NCT00445939
Study group	Role	What they receive
Adalimumab 160 mg/80 mg	Experimental	Not described Receives: Biological: adalimumab
Adalimumab 80 mg/40 mg	Experimental	Not described Receives: Biological: adalimumab
Placebo	Placebo comparator	Not described Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.
Measured: 4 Weeks

Secondary outcomes (4)

Clinical Remission (CDAI < 150) at Week 2
Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2.
Measured: Week 2
Clinical Response (CR-70 and CR-100) in Period A
The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4.
Measured: Weeks 2 and Week 4
Clinical Response (CR-70 and CR-100) in Period B
The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8.
Measured: Week 6 and Week 8
Clinical Remission (CDAI <150) at Week 6 and Week 8
The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8
Measured: Week 6 and Week 8

Timeline

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

Feb 2007Dec 2007

First posted9 Mar 2007 (estimated)
Study startFeb 2007
Primary completionDec 2007

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Crohn's DiseaseStudies 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: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00445939
Sponsor's protocol ID: M04-729
Status last verified: Jun 2011
First submitted: 7 Mar 2007
Last updated: 27 Jun 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, Camez A; Study Investigators. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160-73. doi: 10.1016/j.crohns.2011.07.013. Epub 2011 Aug 26.
PubMed 22325170

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

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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
ClinicalTrials.gov ID: NCT00445939
Acronym / sponsor ID: M04-729
Conditions: Crohn's Disease
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Abbott Japan Co.,Ltd, Eisai Co., Ltd.
Study start: Feb 2007
Primary completion: Dec 2007 (actual)
First posted: 9 Mar 2007 (estimated)
Results: Posted 23 Mar 2009

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 this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Adalimumab 160 mg/80 mg	Experimental	Biological: adalimumab
Adalimumab 80 mg/40 mg	Experimental	Biological: adalimumab
Placebo	Placebo comparator	Biological: placebo

Who may qualify

Ages: 15 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450
If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy

Key exclusion criteria (5 listed)

Ulcerative colitis or indeterminate colitis
History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
Body weight is below 30 kg
Surgical bowel resections within the past 6 months
Females who are pregnant or breast-feeding or considering becoming pregnant during 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, Humira160 mg at Week 0, 80 mg at Week 2	Biological	Adalimumab 160 mg/80 mg
adalimumabAlso: ABT-D2E7, Humira80 mg at Week 0, 40 mg at Week 2	Biological	Adalimumab 80 mg/40 mg
placeboPlacebo at Week 0 and Week 2	Biological	Placebo

Primary outcome

The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
Time frame: 4 Weeks
CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.

4 secondary outcomes

Clinical Remission (CDAI < 150) at Week 2
Time frame: Week 2
Clinical Response (CR-70 and CR-100) in Period A
Time frame: Weeks 2 and Week 4
Clinical Response (CR-70 and CR-100) in Period B
Time frame: Week 6 and Week 8
Clinical Remission (CDAI <150) at Week 6 and Week 8
Time frame: Week 6 and Week 8

Results and safety

Results posted to the registry on 23 Mar 2009, 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 160 mg/80 mg	33	32
Adalimumab 80 mg/40 mg	34	32
Placebo	23	23
Adalimumab 40mg /40 mg	0	0

Primary outcome: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4

Time frame: 4 Weeks. Number. Unit: Particpants

Measure	Adalimumab 160 mg/80 mg n = 33	Adalimumab 80 mg/40 mg n = 34	Placebo n = 23
Value	11	6	3

Population analysed: The primary analysis will be performed on the full analysis set (randomized subjects who received at least one dose of study drug) using the non-responder imputation for missing remission observations.

4 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
Adaliumab 160 mg/80 mg	1 of ?	12 of ?	Not reported
Adalimumab 80 mg/40 mg	3 of ?	15 of ?	Not reported
Placebo	2 of ?	8 of ?	Not reported
Adalimumab 160 mg/80 mg + 40/40 mg	1 of ?	5 of ?	Not reported
80/40 mg + 40/40 mg	1 of ?	9 of ?	Not reported
Placebo + Adalimumab 160/80 mg	0 of ?	8 of ?	Not reported

Limitations and caveats (from the sponsor): Small population, therefore no statistical tests were performed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22325170Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, Camez A; Study Investigators. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160-73. doi: 10.1016/j.crohns.2011.07.013. Epub 2011 Aug 26.

Related trials for Crohn's Disease

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RecruitingObservational study
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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.

Morio Ozawa study director

Abbott Japan Co.,Ltd

18 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 Crohn's Disease, run by Abbott at 18 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 2 inclusion and 5 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 27 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 18 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?

Yes. Results are posted in the registry (first posted 23 Mar 2009). 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?

The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 (time frame: 4 Weeks). 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 NCT00445939, 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 27 Jun 2011.