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

NCT02499783 | Completed Phase 3 Results

• 1 other identifier: M14-233
• Study Type: interventional
• Target: 205
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Crohn's Disease

Keywords

China; Tumor necrosis factor (TNF)-alpha; Biologic

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Week 26

Study Arms (2)

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.

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.

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

subcutaneous injections of adalimumab

Also known as: Humira

Adalimumab Induction Regimen; Placebo Induction Regimen

placebo OTHER

subcutaneous injections of placebo

Placebo Induction Regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• 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. Therap Adv Gastroenterol. 2020 Jul 16;13:1756284820938960. doi: 10.1177/1756284820938960. eCollection 2020.

  PMID: 32733600 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 16, 2015
• Study Start: August 17, 2015
• Primary Completion: May 19, 2017
• Study Completion: December 15, 2017
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-05