A Study of Adalimumab for the Maintenance 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 29 sites in Japan.

Completed

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

Trial summary

To demonstrate the efficacy and safety of adalimumab for the maintenance 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
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 29 sitesJapan
Study dates: Mar 2007to Nov 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 15 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study

Who cannot join

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

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Japan29 sites

Site Ref # / Investigator 46965
Aichi
Site Ref # / Investigator 46977
Aichi
Site Ref # / Investigator 46978
Aichi
Site Ref # / Investigator 46979
Aichi
Site Ref # / Investigator 46922
Chiba
Site Ref # / Investigator 46974
Chiba
Site Ref # / Investigator 46970
Ehime
Site Ref # / Investigator 46971
Fukuoka
Site Ref # / Investigator 46985
Fukuoka
Site Ref # / Investigator 46986
Fukuoka
Site Ref # / Investigator 46987
Fukuoka
Site Ref # / Investigator 46968
Hiroshima
Site Ref # / Investigator 46973
Hokkaido
Site Ref # / Investigator 6881
Hokkaido
Site Ref # / Investigator 46982
Hyōgo
Site Ref # / Investigator 46969
Kagawa
Site Ref # / Investigator 46927
Kanagawa
Site Ref # / Investigator 46984
Kochi
Site Ref # / Investigator 46981
Kyoto
Site Ref # / Investigator 46921
Miyagi
Site Ref # / Investigator 46983
Okayama
Site Ref # / Investigator 46966
Osaka
Site Ref # / Investigator 46967
Osaka
Site Ref # / Investigator 46980
Shiga
Site Ref # / Investigator 46964
Shizuoka
Site Ref # / Investigator 46923
Tokyo
Site Ref # / Investigator 46924
Tokyo
Site Ref # / Investigator 46975
Tokyo
Site Ref # / Investigator 46976
Tokyo

Other trials in Japan

About this study

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

To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.

Read the detailed description

This was a Phase 2/3, multicenter, randomized, double-blind (DB), placebo-controlled, two-arm, efficacy, safety, and pharmacokinetic study designed to demonstrate the effectiveness of adalimumab in Japanese patients with moderate to severe Crohn's Disease (CD).

All participants who had completed Study M04-729 (NCT00445939), the lead-in adalimumab induction therapy study, were eligible for this study. Participants who rolled over into this study received either DB treatment (adalimumab or placebo) or open-label (OL) treatment with adalimumab.

Crohn's Disease Activity Index (CDAI) was used to determine participants who were responders and participants who were in clinical remission. CDAI documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. It yields a total score >= 0 and without upper limit. Baseline scores in the study ranged from 221 to 448. Low score=less severe CD activity. Decrease in score indicates improvement.

Clinical remission is a CDAI score < 150.

Clinical response-70 (CR-70) = decrease in CDAI ≥ 70 points from lead-in study Baseline score.

Clinical response-100 (CR-100) = decrease in CDAI ≥ 100 points from lead-in study Baseline score.

Participants who had CR-70 response at Week 4 of the induction study were randomized into 1 of 2 treatment groups (double-blind adalimumab 40 mg every other week or adalimumab placebo every other week) using 2 stratification factors - CDAI category (CDAI less than 150 and CDAI 150 or higher) and presence/absence of fistula at Week 0 of this study. The double-blind treatment was to last from Week 0 to Week 52. Any time at or after Week 4 of this study, if a participant's disease flared (defined as a recurrence of very active disease, specifically an increase in CDAI when compared to Week 0 in this study of ≥ 70 points and a CDAI above 220) during the double-blind treatment period, the participant was allowed to move to OL treatment. At Week 52, all participants still receiving DB treatment were to be moved to open-label treatment and could continue in the study until adalimumab is approved for commercial use in Japan.

Participants who did not respond by Week 4 in the induction study and participants who had disease flare during DB treatment of this study entered OL treatment and received adalimumab 40 mg every other week. At or after Week 4 of this study, if a participant in the open-label treatment group had a disease flare or if the participant was still not responding to treatment, the participant was allowed to dose escalate to adalimumab 80 mg every other week. Participants who entered open-label treatment were to be allowed to continue on open-label adalimumab until adalimumab is approved for commercial use in Japan.

The study is complete. Results of this study are reported for endpoints at Week 52 (end of the DB treatment period) for subjects who received DB treatment (adalimumab or placebo) or OL adalimumab treatment and for endpoints at Week 148 for all subjects who received at least one dose of adalimumab in this study.

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 Humira, D2E7
Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)
PlaceboOther
Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)

Study groups in NCT00445432
Study group	Role	What they receive
DB Adalimumab 40 mg eow	Experimental	Subjects received double-blind (DB) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the DB treatment period lasting 52 weeks. Receives: Biological: adalimumab
Placebo eow	Placebo comparator	Subjects received placebo subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks. Receives: Other: Placebo
OL Adalimumab 40 mg eow	Experimental	Subjects received open-label (OL) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks. Receives: Biological: adalimumab

What is being measured

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

Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment
Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.
Measured: Week 52 of double-blind treatment

Secondary outcomes (8)

Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Measured: Week 52 of double-blind treatment
Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Measured: Week 52 of double-blind treatment
Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Measured: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment
Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.
Measured: Week 52 of open-label treatment
Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.
Measured: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality (e.g., feeling of fatigue "none of the time"). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life.
Measured: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health).
Measured: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).
Measured: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment

Timeline

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

Mar 2007Nov 2010

First posted9 Mar 2007 (estimated)
Study startMar 2007
Primary completionMar 2009
Study completionNov 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.
Publications (2)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: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00445432
Sponsor's protocol ID: M06-837
Status last verified: Feb 2012
First submitted: 7 Mar 2007
Last updated: 2 Feb 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Watanabe M, Hibi T, Mostafa NM, Chao J, Arora V, Camez A, Petersson J, Thakkar R. Long-term safety and efficacy of adalimumab in Japanese patients with moderate to severe Crohn's disease. J Crohns Colitis. 2014 Nov;8(11):1407-16. doi: 10.1016/j.crohns.2014.04.012. Epub 2014 May 27.
PubMed 24874893
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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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2012. 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 Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
ClinicalTrials.gov ID: NCT00445432
Acronym / sponsor ID: M06-837
Conditions: Crohn's Disease
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Eisai Co., Ltd.
Study start: Mar 2007
Primary completion: Mar 2009 (actual)
Study completion: Nov 2010 (actual)
First posted: 9 Mar 2007 (estimated)
Results: Posted 9 Jun 2010

Clinical summary

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

To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.

Detailed description

Clinical remission is a CDAI score < 150.

Clinical response-70 (CR-70) = decrease in CDAI ≥ 70 points from lead-in study Baseline score.

Clinical response-100 (CR-100) = decrease in CDAI ≥ 100 points from lead-in study Baseline score.

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
DB Adalimumab 40 mg eow	Experimental	Biological: adalimumabSubjects received double-blind (DB) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the DB treatment period lasting 52 weeks.
Placebo eow	Placebo comparator	Other: PlaceboSubjects received placebo subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.
OL Adalimumab 40 mg eow	Experimental	Biological: adalimumabSubjects received open-label (OL) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.

Who may qualify

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

Key inclusion criteria (1 listed)

Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study

Key exclusion criteria (1 listed)

Subject 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: Humira, D2E7Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)	Biological	DB Adalimumab 40 mg eow, OL Adalimumab 40 mg eow
PlaceboSubcutaneous injection of placebo (0.8 mL/injection) every other week (eow)	Other	Placebo eow

Primary outcome

Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment
Time frame: Week 52 of double-blind treatment
Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.

8 secondary outcomes

Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
Time frame: Week 52 of double-blind treatment
Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
Time frame: Week 52 of double-blind treatment
Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Time frame: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment
Time frame: Week 52 of open-label treatment
Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Time frame: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Time frame: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Time frame: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment
Time frame: Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment

Results and safety

Results posted to the registry on 9 Jun 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
DB Adalimumab 40 mg Eow	25	10
Placebo Eow	25	2
OL Adalimumab 40 mg Eow	32	21
Any Adalimumab	0	0

Primary outcome: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment

Time frame: Week 52 of double-blind treatment. Number. Unit: Participants

Measure	DB Adalimumab 40 mg Eow n = 21	Placebo Eow n = 22
Value	8	2

Population analysed: Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks for the double-blind (DB) treatments (adalimumab and placebo) and for the open-label adalimumab treatment. Overall study (maximum adalimumab treatment of 184 weeks plus 70-day follow-up period) for the Any Adalimumab group.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DB Adalimumab 40 mg Eow	2 of 25 (8%)	17 of 25 (68%)	Not reported
Placebo Eow	6 of 25 (24%)	13 of 25 (52%)	Not reported
OL Adalimumab 40 mg Eow	13 of 32 (40.6%)	28 of 32 (87.5%)	Not reported
Any Adalimumab	49 of 79 (62%)	73 of 79 (92.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24874893Watanabe M, Hibi T, Mostafa NM, Chao J, Arora V, Camez A, Petersson J, Thakkar R. Long-term safety and efficacy of adalimumab in Japanese patients with moderate to severe Crohn's disease. J Crohns Colitis. 2014 Nov;8(11):1407-16. doi: 10.1016/j.crohns.2014.04.012. Epub 2014 May 27.
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.

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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.

Kazuko Kobayashi study director

Abbott

29 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 29 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 9 Jun 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 Who Had Clinical Remission at Week 52 of Double-blind Treatment (time frame: Week 52 of double-blind treatment). 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 NCT00445432, which also lists 2 linked publications.

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 2 Feb 2012.