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Adalimumab for the Management of Post-operative Crohn's Disease (CD)

NCT01629628 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-06-27

No results posted yet for this study

Summary

This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence.

Patient assessment for efficacy will be conducted through interval endoscopic surveillance at 24 and 52 weeks.

Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks.

The investigators expect a substantial increase in both endoscopic, as well as clinical remission rate in patients on adalimumab therapy.

Conditions

  • Crohn Disease

Interventions

DRUG

Adalimumab

Subcutaneous adalimumab injections, loading dose of 160 mg and 80 mg on 0 and 2 weeks and maintenance of 40 mg every other week for the duration of the study.

DRUG

6 Mercaptopurine

6MP will be administered orally starting at a dose of 6MP of 50mg/day with escalating doses every 1-2 weeks as tolerated, to a target dose of 1-1.5 mg/kg. \--------------------------------------------------------------------------------

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Erez F Scapa, M.D. · Tel-Aviv Sourasky Medical Center, Affiliated to Tel-Aviv University

  • Iris Dotan, M.D. · Tel-Aviv Sourasky Medical Center, Affiliated to Tel-Aviv University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Israel

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01629628 on ClinicalTrials.gov