Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

An observational study of Crohn's Disease, run by AbbVie (prior sponsor, Abbott) at 1,131 sites in Japan.

Completed

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

Trial summary

This study will be conducted to assess adverse drug reactions, incidence of adverse events, and factors that may affect the safety and effectiveness of Humira for the treatment of Crohn's disease. Read more about this study

Who is it for?: Ages 16 to 99 years
Conditions the study is for: Crohn's Disease
How many people: 1,716 participants
Where: 1,131 sitesJapan
Study dates: Nov 2010to Feb 2013
Phase: Observational
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 16 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patients who receive Humira for the treatment of Crohn's Disease

Who may be able to join

All patients with moderate or severe active Crohn's disease who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Who cannot join

Contraindications according to the Package Insert
Patients who have serious infections
Patients who have tuberculosis
Patients with a history of hypersensitivity to any ingredient of Humira
Patients who have demyelinating disease or with a history of demyelinating disease
Patients who have congestive cardiac failure

Trial locations and contacts

1,131 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Japan300 sites

Site Reference ID/Investigator# 60378
Abiko
Site Reference ID/Investigator# 48682
Aichi
Site Reference ID/Investigator# 48693
Aichi
Site Reference ID/Investigator# 49011
Aichi
Site Reference ID/Investigator# 49013
Aichi
Site Reference ID/Investigator# 49015
Aichi
Site Reference ID/Investigator# 49016
Aichi
Site Reference ID/Investigator# 49019
Aichi
Site Reference ID/Investigator# 55615
Aichi
Site Reference ID/Investigator# 55616
Aichi
Site Reference ID/Investigator# 55865
Aichi
Site Reference ID/Investigator# 55869
Aichi
Site Reference ID/Investigator# 55870
Aichi
Site Reference ID/Investigator# 55871
Aichi
Site Reference ID/Investigator# 55872
Aichi
Site Reference ID/Investigator# 55873
Aichi
Site Reference ID/Investigator# 55874
Aichi
Site Reference ID/Investigator# 55875
Aichi
Site Reference ID/Investigator# 55876
Aichi
Site Reference ID/Investigator# 55877
Aichi
Site Reference ID/Investigator# 60203
Aichi
Site Reference ID/Investigator# 60205
Aichi
Site Reference ID/Investigator# 60244
Aichi
Site Reference ID/Investigator# 60508
Aichi
Site Reference ID/Investigator# 65148
Aichi
Site Reference ID/Investigator# 67162
Aichi
Site Reference ID/Investigator# 48652
Aizu-Wakamatsu
Site Reference ID/Investigator# 55758
Akashi
Site Reference ID/Investigator# 89873
Akashi
Site Reference ID/Investigator# 60398
Aki-gun, Hiroshima
Site Reference ID/Investigator# 60401
Aki-gun, Hiroshima
Site Reference ID/Investigator# 48650
Akita
Site Reference ID/Investigator# 55660
Akita
Site Reference ID/Investigator# 55705
Akita
Site Reference ID/Investigator# 55905
Akita
Site Reference ID/Investigator# 55906
Akita
Site Reference ID/Investigator# 55907
Akita
Site Reference ID/Investigator# 55909
Akita
Site Reference ID/Investigator# 60190
Akita
Site Reference ID/Investigator# 60261
Akita
Site Reference ID/Investigator# 60376
Akita
Site Reference ID/Investigator# 55742
Amagasaki
Site Reference ID/Investigator# 56030
Anan
Site Reference ID/Investigator# 49026
Anjo
Site Reference ID/Investigator# 55617
Anjo
Site Reference ID/Investigator# 48797
Aomori
Site Reference ID/Investigator# 55584
Aomori
Site Reference ID/Investigator# 55585
Aomori
Site Reference ID/Investigator# 55897
Aomori
Site Reference ID/Investigator# 55898
Aomori
Site Reference ID/Investigator# 55899
Aomori
Site Reference ID/Investigator# 55900
Aomori
Site Reference ID/Investigator# 60509
Aomori
Site Reference ID/Investigator# 65111
Aomori
Site Reference ID/Investigator# 65144
Aomori
Site Reference ID/Investigator# 80014
Aomori
Site Reference ID/Investigator# 48648
Asahikawa
Site Reference ID/Investigator# 55797
Asahikawa
Site Reference ID/Investigator# 56032
Awa
Site Reference ID/Investigator# 55778
Ayabe
Site Reference ID/Investigator# 80233
Azumino
Site Reference ID/Investigator# 80220
Beppu
Site Reference ID/Investigator# 48668
Chiba
Site Reference ID/Investigator# 48672
Chiba
Site Reference ID/Investigator# 49000
Chiba
Site Reference ID/Investigator# 49002
Chiba
Site Reference ID/Investigator# 49006
Chiba
Site Reference ID/Investigator# 55647
Chiba
Site Reference ID/Investigator# 55796
Chiba
Site Reference ID/Investigator# 55820
Chiba
Site Reference ID/Investigator# 55821
Chiba
Site Reference ID/Investigator# 55822
Chiba
Site Reference ID/Investigator# 55826
Chiba
Site Reference ID/Investigator# 55827
Chiba
Site Reference ID/Investigator# 55841
Chiba
Site Reference ID/Investigator# 60257
Chiba
Site Reference ID/Investigator# 65115
Chiba
Site Reference ID/Investigator# 65116
Chiba
Site Reference ID/Investigator# 65117
Chiba
Site Reference ID/Investigator# 65138
Chiba
Site Reference ID/Investigator# 67169
Chiba
Site Reference ID/Investigator# 79900
Chiba
Site Reference ID/Investigator# 89820
Chichibu
Site Reference ID/Investigator# 49074
Chikushino-shi
Site Reference ID/Investigator# 55880
Chita
Site Reference ID/Investigator# 60210
Chita
Site Reference ID/Investigator# 55886
Chitose
Site Reference ID/Investigator# 55920
Chūō
Site Reference ID/Investigator# 80236
Ebetsu
Site Reference ID/Investigator# 49076
Ehime
Site Reference ID/Investigator# 55583
Ehime
Site Reference ID/Investigator# 56026
Ehime
Site Reference ID/Investigator# 56044
Ehime
Site Reference ID/Investigator# 65155
Ehime
Site Reference ID/Investigator# 79935
Esashi
Site Reference ID/Investigator# 89827
Fuji
Site Reference ID/Investigator# 48688
Fujieda
Site Reference ID/Investigator# 48689
Fujinomiya
Site Reference ID/Investigator# 79876
Fujisawa
Site Reference ID/Investigator# 48744
Fukui
Site Reference ID/Investigator# 55190
Fukui
Site Reference ID/Investigator# 55312
Fukui
Site Reference ID/Investigator# 55771
Fukui
Site Reference ID/Investigator# 55793
Fukui
Site Reference ID/Investigator# 80234
Fukui
Site Reference ID/Investigator# 48760
Fukuoka
Site Reference ID/Investigator# 48761
Fukuoka
Site Reference ID/Investigator# 48762
Fukuoka
Site Reference ID/Investigator# 48763
Fukuoka
Site Reference ID/Investigator# 48764
Fukuoka
Site Reference ID/Investigator# 48767
Fukuoka
Site Reference ID/Investigator# 48784
Fukuoka
Site Reference ID/Investigator# 49069
Fukuoka
Site Reference ID/Investigator# 49080
Fukuoka
Site Reference ID/Investigator# 49083
Fukuoka
Site Reference ID/Investigator# 49084
Fukuoka
Site Reference ID/Investigator# 49086
Fukuoka
Site Reference ID/Investigator# 55305
Fukuoka
Site Reference ID/Investigator# 56036
Fukuoka
Site Reference ID/Investigator# 56037
Fukuoka
Site Reference ID/Investigator# 56040
Fukuoka
Site Reference ID/Investigator# 56041
Fukuoka
Site Reference ID/Investigator# 56042
Fukuoka
Site Reference ID/Investigator# 56043
Fukuoka
Site Reference ID/Investigator# 56048
Fukuoka
Site Reference ID/Investigator# 56052
Fukuoka
Site Reference ID/Investigator# 60426
Fukuoka
Site Reference ID/Investigator# 60530
Fukuoka
Site Reference ID/Investigator# 60558
Fukuoka
Site Reference ID/Investigator# 65130
Fukuoka
Site Reference ID/Investigator# 65131
Fukuoka
Site Reference ID/Investigator# 65146
Fukuoka
Site Reference ID/Investigator# 65151
Fukuoka
Site Reference ID/Investigator# 68637
Fukuoka
Site Reference ID/Investigator# 68638
Fukuoka
Site Reference ID/Investigator# 90413
Fukuoka
Site Reference ID/Investigator# 48984
Fukushima
Site Reference ID/Investigator# 55163
Fukushima
Site Reference ID/Investigator# 55316
Fukushima
Site Reference ID/Investigator# 55597
Fukushima
Site Reference ID/Investigator# 55720
Fukushima
Site Reference ID/Investigator# 55798
Fukushima
Site Reference ID/Investigator# 55947
Fukushima
Site Reference ID/Investigator# 55948
Fukushima
Site Reference ID/Investigator# 55949
Fukushima
Site Reference ID/Investigator# 55950
Fukushima
Site Reference ID/Investigator# 55951
Fukushima
Site Reference ID/Investigator# 60196
Fukushima
Site Reference ID/Investigator# 60248
Fukushima
Site Reference ID/Investigator# 60386
Fukushima
Site Reference ID/Investigator# 60563
Fukushima
Site Reference ID/Investigator# 90396
Fukushima
Site Reference ID/Investigator# 55789
Fukuyama
Site Reference ID/Investigator# 56000
Fukuyama
Site Reference ID/Investigator# 90416
Fukuyama
Site Reference ID/Investigator# 48697
Gifu
Site Reference ID/Investigator# 49020
Gifu
Site Reference ID/Investigator# 49022
Gifu
Site Reference ID/Investigator# 55319
Gifu
Site Reference ID/Investigator# 55620
Gifu
Site Reference ID/Investigator# 55621
Gifu
Site Reference ID/Investigator# 55624
Gifu
Site Reference ID/Investigator# 55626
Gifu
Site Reference ID/Investigator# 55627
Gifu
Site Reference ID/Investigator# 55629
Gifu
Site Reference ID/Investigator# 60246
Gifu
Site Reference ID/Investigator# 60258
Gifu
Site Reference ID/Investigator# 60262
Gifu
Site Reference ID/Investigator# 60368
Gifu
Site Reference ID/Investigator# 60387
Gifu
Site Reference ID/Investigator# 60412
Gifu
Site Reference ID/Investigator# 60423
Gifu
Site Reference ID/Investigator# 60556
Gifu
Site Reference ID/Investigator# 60559
Gifu
Site Reference ID/Investigator# 67159
Gifu
Site Reference ID/Investigator# 48998
Gunma
Site Reference ID/Investigator# 55965
Gunma
Site Reference ID/Investigator# 55966
Gunma
Site Reference ID/Investigator# 55968
Gunma
Site Reference ID/Investigator# 60192
Gunma
Site Reference ID/Investigator# 60214
Gunma
Site Reference ID/Investigator# 60380
Gunma
Site Reference ID/Investigator# 65105
Gunma
Site Reference ID/Investigator# 67157
Gunma
Site Reference ID/Investigator# 67158
Gunma
Site Reference ID/Investigator# 55902
Hachinohe
Site Reference ID/Investigator# 60363
Hachinohe
Site Reference ID/Investigator# 48646
Hakodate
Site Reference ID/Investigator# 89856
Hakodate
Site Reference ID/Investigator# 48690
Hamamatsu
Site Reference ID/Investigator# 48691
Hamamatsu
Site Reference ID/Investigator# 55317
Hamamatsu
Site Reference ID/Investigator# 55613
Hamamatsu
Site Reference ID/Investigator# 55790
Hamamatsu
Site Reference ID/Investigator# 89817
Hamamatsu
Site Reference ID/Investigator# 55622
Hashima
Site Reference ID/Investigator# 55623
Hashima
Site Reference ID/Investigator# 56001
Higashihiroshima
Site Reference ID/Investigator# 55794
Higashiosaka
Site Reference ID/Investigator# 71467
Higashiosaka
Site Reference ID/Investigator# 55593
Himeji
Site Reference ID/Investigator# 55599
Himeji
Site Reference ID/Investigator# 55703
Himeji
Site Reference ID/Investigator# 90401
Himeji
Site Reference ID/Investigator# 55650
Hirakata
Site Reference ID/Investigator# 55311
Hirosaki
Site Reference ID/Investigator# 89813
Hirosaki
Site Reference ID/Investigator# 48751
Hiroshima
Site Reference ID/Investigator# 49063
Hiroshima
Site Reference ID/Investigator# 49064
Hiroshima
Site Reference ID/Investigator# 49068
Hiroshima
Site Reference ID/Investigator# 55164
Hiroshima
Site Reference ID/Investigator# 55574
Hiroshima
Site Reference ID/Investigator# 55581
Hiroshima
Site Reference ID/Investigator# 55601
Hiroshima
Site Reference ID/Investigator# 55694
Hiroshima
Site Reference ID/Investigator# 55997
Hiroshima
Site Reference ID/Investigator# 56002
Hiroshima
Site Reference ID/Investigator# 56003
Hiroshima
Site Reference ID/Investigator# 56004
Hiroshima
Site Reference ID/Investigator# 56005
Hiroshima
Site Reference ID/Investigator# 56007
Hiroshima
Site Reference ID/Investigator# 56008
Hiroshima
Site Reference ID/Investigator# 56010
Hiroshima
Site Reference ID/Investigator# 56014
Hiroshima
Site Reference ID/Investigator# 60554
Hiroshima
Site Reference ID/Investigator# 60560
Hiroshima
Site Reference ID/Investigator# 55588
Hitachi
Site Reference ID/Investigator# 56068
Hitoyoshi
Site Reference ID/Investigator# 48643
Hokkaido
Site Reference ID/Investigator# 48644
Hokkaido
Site Reference ID/Investigator# 48645
Hokkaido
Site Reference ID/Investigator# 48788
Hokkaido
Site Reference ID/Investigator# 48792
Hokkaido
Site Reference ID/Investigator# 48793
Hokkaido
Site Reference ID/Investigator# 48795
Hokkaido
Site Reference ID/Investigator# 48796
Hokkaido
Site Reference ID/Investigator# 55315
Hokkaido
Site Reference ID/Investigator# 55785
Hokkaido
Site Reference ID/Investigator# 55791
Hokkaido
Site Reference ID/Investigator# 55804
Hokkaido
Site Reference ID/Investigator# 55878
Hokkaido
Site Reference ID/Investigator# 55885
Hokkaido
Site Reference ID/Investigator# 55887
Hokkaido
Site Reference ID/Investigator# 55888
Hokkaido
Site Reference ID/Investigator# 55889
Hokkaido
Site Reference ID/Investigator# 55891
Hokkaido
Site Reference ID/Investigator# 55892
Hokkaido
Site Reference ID/Investigator# 55893
Hokkaido
Site Reference ID/Investigator# 55894
Hokkaido
Site Reference ID/Investigator# 55895
Hokkaido
Site Reference ID/Investigator# 60193
Hokkaido
Site Reference ID/Investigator# 60201
Hokkaido
Site Reference ID/Investigator# 60540
Hokkaido
Site Reference ID/Investigator# 60552
Hokkaido
Site Reference ID/Investigator# 60557
Hokkaido
Site Reference ID/Investigator# 65109
Hokkaido
Site Reference ID/Investigator# 65110
Hokkaido
Site Reference ID/Investigator# 48755
Houfu
Site Reference ID/Investigator# 80219
Houfu
Site Reference ID/Investigator# 48707
Hyōgo
Site Reference ID/Investigator# 48708
Hyōgo
Site Reference ID/Investigator# 48710
Hyōgo
Site Reference ID/Investigator# 48712
Hyōgo
Site Reference ID/Investigator# 48713
Hyōgo
Site Reference ID/Investigator# 49042
Hyōgo
Site Reference ID/Investigator# 49046
Hyōgo
Site Reference ID/Investigator# 49047
Hyōgo
Site Reference ID/Investigator# 55156
Hyōgo
Site Reference ID/Investigator# 55691
Hyōgo
Site Reference ID/Investigator# 55743
Hyōgo
Site Reference ID/Investigator# 55744
Hyōgo
Site Reference ID/Investigator# 55746
Hyōgo
Site Reference ID/Investigator# 55748
Hyōgo
Site Reference ID/Investigator# 55749
Hyōgo
Site Reference ID/Investigator# 55750
Hyōgo
Site Reference ID/Investigator# 55752
Hyōgo
Site Reference ID/Investigator# 55753
Hyōgo
Site Reference ID/Investigator# 55755
Hyōgo
Site Reference ID/Investigator# 55756
Hyōgo
Site Reference ID/Investigator# 55757
Hyōgo
Site Reference ID/Investigator# 55759
Hyōgo
Site Reference ID/Investigator# 60215
Hyōgo
Site Reference ID/Investigator# 60224
Hyōgo
Site Reference ID/Investigator# 60251
Hyōgo
Site Reference ID/Investigator# 60364
Hyōgo
Site Reference ID/Investigator# 60388
Hyōgo
Site Reference ID/Investigator# 60389
Hyōgo
Site Reference ID/Investigator# 60402
Hyōgo
Site Reference ID/Investigator# 60528
Hyōgo
Site Reference ID/Investigator# 60531
Hyōgo
Site Reference ID/Investigator# 65143
Hyōgo
Site Reference ID/Investigator# 68641
Hyōgo
Site Reference ID/Investigator# 48994
Ibaraki
Site Reference ID/Investigator# 49008
Ibaraki
Site Reference ID/Investigator# 55596
Ibaraki
Site Reference ID/Investigator# 55693
Ibaraki
Site Reference ID/Investigator# 55955
Ibaraki
Site Reference ID/Investigator# 55957
Ibaraki
Site Reference ID/Investigator# 55958
Ibaraki

Other trials in Japan

About this study

Official title: Special Investigation (All Cases Investigation in Patients With Crohn's Disease)

This study will be conducted to assess adverse drug reactions, incidence of adverse events, and factors that may affect the safety and effectiveness of Humira for the treatment of Crohn's disease.

Conditions: Crohn's Disease
Keywords: Crohn's Disease
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01298648
Study group	Role	What they receive
Humira		Participants who were prescribed Humira per approved prescribing information of Humira in Japan.

What is being measured

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

Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Measured: 24 weeks
Crohn's Disease Activity Index (CDAI) at Baseline and Week 4
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Measured: Baseline, Week 4
Crohn's Disease Activity Index (CDAI) at Baseline and Week 8
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Measured: Baseline, Week 8
Crohn's Disease Activity Index (CDAI) at Baseline and Week 24
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Measured: Baseline, Week 24

Secondary outcomes (2)

Improvement Rating by Investigator at Week 24
Overall response rating, according to investigator's subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.
Measured: Week 24
Remission Rate at Week 4, Week 8, and Week 24
The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.
Measured: Baseline, Week 4, Week 8, and Week 24

Timeline

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

Nov 2010Feb 2013

First posted18 Feb 2011 (estimated)
Study startNov 2010
Primary completionFeb 2013
Study completionFeb 2013

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,716 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01298648
Sponsor's protocol ID: P12-706
Status last verified: Mar 2014
First submitted: 26 Jan 2011
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Ogata H, Watanabe M, Matsui T, Hase H, Okayasu M, Tsuchiya T, Shinmura Y, Hibi T. Safety of Adalimumab and Predictors of Adverse Events in 1693 Japanese Patients with Crohn's Disease. J Crohns Colitis. 2016 Sep;10(9):1033-41. doi: 10.1093/ecco-jcc/jjw060. Epub 2016 Mar 9.
PubMed 26961546

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 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Investigation (All Cases Investigation in Patients With Crohn's Disease)
ClinicalTrials.gov ID: NCT01298648
Acronym / sponsor ID: P12-706
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,716 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 18 Feb 2011 (estimated)
Results: Posted 18 Mar 2014

Clinical summary

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

This study will be conducted to assess adverse drug reactions, incidence of adverse events, and factors that may affect the safety and effectiveness of Humira for the treatment of Crohn's disease.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Humira	–	–Participants who were prescribed Humira per approved prescribing information of Humira in Japan.

Who may qualify

Ages: 16 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients who receive Humira for the treatment of Crohn's Disease

Key inclusion criteria (1 listed)

All patients with moderate or severe active Crohn's disease who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Key exclusion criteria (6 listed)

Contraindications according to the Package Insert
Patients who have serious infections
Patients who have tuberculosis
Patients with a history of hypersensitivity to any ingredient of Humira
Patients who have demyelinating disease or with a history of demyelinating disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: 24 weeks
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Crohn's Disease Activity Index (CDAI) at Baseline and Week 4
Time frame: Baseline, Week 4
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Crohn's Disease Activity Index (CDAI) at Baseline and Week 8
Time frame: Baseline, Week 8
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.
Crohn's Disease Activity Index (CDAI) at Baseline and Week 24
Time frame: Baseline, Week 24
The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.

2 secondary outcomes

Improvement Rating by Investigator at Week 24
Time frame: Week 24
Remission Rate at Week 4, Week 8, and Week 24
Time frame: Baseline, Week 4, Week 8, and Week 24

Results and safety

Results posted to the registry on 18 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Humira	1,716	1,693

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: 24 weeks. Number. Unit: participants

Measure	Humira n = 1693
AEs	453
SAEs	147
ADRs	360
SADRs	96

Population analysed: Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.

Primary outcome: Crohn's Disease Activity Index (CDAI) at Baseline and Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: scores on a scale

Measure	Humira n = 1017
Baseline (n=1017)	204.3 (105.7)
Week 4 (n=912)	142.9 (90.4)

Humira: p <0.0001, t-test, 2 sided

Population analysed: Participants with available data at each time point.

Primary outcome: Crohn's Disease Activity Index (CDAI) at Baseline and Week 8

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: scores on a scale

Measure	Humira n = 1017
Baseline (n=1017)	204.3 (105.7)
Week 8 (n=818)	142.7 (93.8)

Humira: p <0.0001, t-test, 1 sided

Population analysed: Participants with available data at each time point.

Primary outcome: Crohn's Disease Activity Index (CDAI) at Baseline and Week 24

Time frame: Baseline, Week 24. Mean (Standard Deviation). Unit: scores on a scale

Measure	Humira n = 1017
Baseline (n=1017)	204.3 (105.7)
Week 24 (n=982)	149.1 (100.9)

Humira: p <0.0001, t-test, 2 sided

Population analysed: Participants with available data at each time point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Humira	147 of 1,693 (8.7%)	177 of 1,693 (10.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26961546Ogata H, Watanabe M, Matsui T, Hase H, Okayasu M, Tsuchiya T, Shinmura Y, Hibi T. Safety of Adalimumab and Predictors of Adverse Events in 1693 Japanese Patients with Crohn's Disease. J Crohns Colitis. 2016 Sep;10(9):1033-41. doi: 10.1093/ecco-jcc/jjw060. Epub 2016 Mar 9.
Related InfoLink provided by the sponsor.

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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.

Sadanori Abe study director

AbbVie

1,131 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by AbbVie (prior sponsor, Abbott) at 1,131 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 6 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,131 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2014). 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 Adverse Events (AEs) (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 NCT01298648, 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 2 Jul 2018.