Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

A Phase 3 study testing adalimumab in people with Crohn's Disease, run by AbbVie.

Completed

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

Trial summary

This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China. Read more about this study

Who is it for?: Ages 18 to 70 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: 205 participants
Where: No sites listed yet
Study dates: 17 Aug 2015to 15 Dec 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects of Chinese descent with full Chinese parentage.
Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.
Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.
Subject has a negative Tuberculosis (TB) Screening Assessment.
Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.

Who cannot join

Subject with ulcerative colitis or indeterminate colitis.
Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.
Subject with an ostomy or ileoanal pouch.
Subject who has short bowel syndrome.
Subject with symptomatic known obstructive strictures.
Subject with an internal or external fistula (with the exception of an anal fistula without abscess).
Active, or chronic or recurring infections, or active tuberculosis.

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein

This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.

Conditions: Crohn's Disease
Being tested: adalimumab, placebo
Keywords: China, Tumor necrosis factor (TNF)-alpha, Biologic
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
subcutaneous injections of adalimumab
placeboOther
subcutaneous injections of placebo

Study groups in NCT02499783
Study group	Role	What they receive
Placebo Induction Regimen	Experimental	Double-blind period (Weeks 0-8): Placebo at Weeks 0 and 2, followed by adalimumab 160 mg at Week 4, 80 mg at Week 6. Open label period: adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24. Receives: Biological: adalimumab; Other: placebo
Adalimumab Induction Regimen	Experimental	Double-blind period (Weeks 0-8): adalimumab 160 mg at Weeks 0 and 80 mg at Week 2, followed by adalimumab 40 mg at Week 4 and Week 6. Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24. Receives: Biological: adalimumab

What is being measured

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

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 4

Secondary outcomes (27)

Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 26
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8
Clinical response is defined as a decrease in CDAI ≥ 70 Points from Baseline
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 26
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 26
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8
Percentage of participants who discontinued corticosteroid use and achieved clinical remission (CDAI < 150) plus a reduction in hs-CRP of at least 50% from Baseline at Week 26 in participants who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI of ≥ 70 points from Baseline) plus a reduction in hs-CRP of ≥ 30% From Baseline at Week 8.
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 26
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 4
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 26
Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Measured: Week 4
Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 26
Change From Baseline in Fecal Calprotectin Level at Week 4
Measured: Baseline, Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Measured: Week 26
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Measured: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Measured: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Measured: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Measured: Weeks 2, 4, 6, 8, 12, 16, 20, 26
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Measured: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Measured: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Measured: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Measured: Weeks 2, 4, 6, 8, 12, 16, 20, 26
Change From Baseline in CDAI Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Measured: Baseline, Weeks 2, 4
Change From Baseline in CDAI Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Measured: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Measured: Baseline, Weeks 2, 4
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Measured: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26
Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Measured: Baseline (Week 0 of adalimumab), Weeks 4, 8, 26

Timeline

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

17 Aug 201515 Dec 2017

First posted16 Jul 2015 (estimated)
Study start17 Aug 2015
Primary completion19 May 2017
Study completion15 Dec 2017

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.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02499783
Sponsor's protocol ID: M14-233
Status last verified: May 2018
First submitted: 14 Jul 2015
Last updated: 4 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Chen B, Gao X, Zhong J, Ren J, Zhu X, Liu Z, Wu K, Kalabic J, Yu Z, Huang B, Kwatra N, Doan T, Robinson AM, Chen MH. Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial. Ther Adv Gastroenterol. 2020 Jul 16;13:1756284820938960. doi: 10.1177/1756284820938960. eCollection 2020.
PubMed 32733600

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?

Official record

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein
ClinicalTrials.gov ID: NCT02499783
Acronym / sponsor ID: M14-233
Conditions: Crohn's Disease
Keywords: China, Tumor necrosis factor (TNF)-alpha, Biologic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 17 Aug 2015 (actual)
Primary completion: 19 May 2017 (actual)
Study completion: 15 Dec 2017 (actual)
First posted: 16 Jul 2015 (estimated)
Results: Posted 4 Jan 2019

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 evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Induction Regimen	Experimental	Biological: adalimumab, Other: placeboDouble-blind period (Weeks 0-8): Placebo at Weeks 0 and 2, followed by adalimumab 160 mg at Week 4, 80 mg at Week 6. Open label period: adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.
Adalimumab Induction Regimen	Experimental	Biological: adalimumabDouble-blind period (Weeks 0-8): adalimumab 160 mg at Weeks 0 and 80 mg at Week 2, followed by adalimumab 40 mg at Week 4 and Week 6. Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects of Chinese descent with full Chinese parentage.
Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.
Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.
Subject has a negative Tuberculosis (TB) Screening Assessment.
Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.

Key exclusion criteria (7 listed)

Subject with ulcerative colitis or indeterminate colitis.
Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.
Subject with an ostomy or ileoanal pouch.
Subject who has short bowel syndrome.
Subject with symptomatic known obstructive strictures.

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: Humirasubcutaneous injections of adalimumab	Biological	Adalimumab Induction Regimen, Placebo Induction Regimen
placebosubcutaneous injections of placebo	Other	Placebo Induction Regimen

Primary outcome

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4
Time frame: Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.

27 secondary outcomes

Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
Time frame: Week 26
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4
Time frame: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8
Time frame: Week 26
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
Time frame: Week 26
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8
Time frame: Week 26
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4
Time frame: Week 4
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4
Time frame: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4
Time frame: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
Time frame: Week 26
Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4
Time frame: Week 4
Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
Time frame: Week 26
Change From Baseline in Fecal Calprotectin Level at Week 4
Time frame: Baseline, Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4
Time frame: Week 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
Time frame: Week 26
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4
Time frame: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)
Time frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4
Time frame: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set)
Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 26
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4
Time frame: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set)
Time frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4
Time frame: Weeks 2, 4
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set)
Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 26
Change From Baseline in CDAI Over Double-Blind Weeks 0-4
Time frame: Baseline, Weeks 2, 4
Change From Baseline in CDAI Over Time (Any Adalimumab Set)
Time frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4
Time frame: Baseline, Weeks 2, 4
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)
Time frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26
Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)
Time frame: Baseline (Week 0 of adalimumab), Weeks 4, 8, 26

Results and safety

Results posted to the registry on 4 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Double-Blind (DB) Period: Adalimumab 160/80/40 mg	102	98
DB Period: Placebo Followed by Adalimumab 160/80 mg	103	98
Open-Label (OL) Period: Adalimumab 40 mg	0	0

Primary outcome: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4

Time frame: Week 4. Number. Unit: percentage of participants

Measure	Double-Blind Period, Weeks 0 to 4: Placebo n = 103	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n = 102
Value	6.8	37.3

Double-Blind Period, Weeks 0 to 4: Placebo vs Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg: Adjusted Risk Difference: 30.4 (95% CI 19.2 to 41.7), p <0.001, Cochran-Mantel-Haenszel

Population analysed: Intention to Treat (ITT) Set: all participants who were randomized. Non-responder imputation.

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-Blind Placebo Weeks 0-4	1 of 103 (1%)	18 of 103 (17.5%)	0 of 103
Double-Blind Adalimumab 160/80 mg Weeks 0-4	2 of 102 (2%)	25 of 102 (24.5%)	0 of 102
Any Adalimumab	36 of 200 (18%)	137 of 200 (68.5%)	0 of 200

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32733600Chen B, Gao X, Zhong J, Ren J, Zhu X, Liu Z, Wu K, Kalabic J, Yu Z, Huang B, Kwatra N, Doan T, Robinson AM, Chen MH. Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial. Ther Adv Gastroenterol. 2020 Jul 16;13:1756284820938960. doi: 10.1177/1756284820938960. eCollection 2020.
Individual participant dataSharing planned: Undecided

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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.

AbbVie Inc. study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab in people with Crohn's Disease, run by AbbVie.

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 5 inclusion and 7 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 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2019). 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?

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 (time frame: Week 4). 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 NCT02499783, 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 4 Jan 2019.