Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

NCT02015793 | Completed Phase 2 Results

• 1 other identifier: M14-232
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Mean Serum Adalimumab Concentration at Week 8

  Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.

  Week 8

Secondary Outcomes (9)

• Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab

  26 weeks

• Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab

  From Week 0 to Week 26

• Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab

  26 weeks

• Number of Participants With Adverse Events (AEs)

  35 weeks

• Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26

  Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

Other Outcomes (1)

• Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8

  Baseline (Week 0) to Week 8

Study Arms (2)

Low Induction Dose

EXPERIMENTAL

Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.

Biological: Adalimumab; Biological: Placebo for adalimumab

Standard Induction Dose

EXPERIMENTAL

Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection.

Low Induction Dose; Standard Induction Dose

Placebo for adalimumab BIOLOGICAL

Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.

Low Induction Dose

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 confirmed by endoscopy, radiologic evaluation, and/or histology during the Screening Period.
• Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450 despite treatment with oral corticosteroids and/or immunosuppressants.
• Subject has a negative Tuberculosis (TB) Screening Assessment.

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).
• Chronic recurring infections or active TB.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Wu KC, Ran ZH, Gao X, Chen M, Zhong J, Sheng JQ, Kamm MA, Travis S, Wallace K, Mostafa NM, Shapiro M, Li Y, Thakkar RB, Robinson AM. Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease. Intest Res. 2016 Apr;14(2):152-63. doi: 10.5217/ir.2016.14.2.152. Epub 2016 Apr 27.

  PMID: 27175116 RESULT

Related Links

• Related Info.

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

800-633-9110

Study Officials

• Anne Robinson

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 30, 2018
• Results First Posted: May 13, 2016

Record last verified: 2016-04