NCT00304252

Brief Summary

The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2001

Geographic Reach
5 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

First QC Date

March 14, 2006

Last Update Submit

August 4, 2013

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26.

Secondary Outcomes (4)

  • The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures:

  • The proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 52

  • Time to relapse

  • Change from baseline to end of treatment in Quality of Life (IBDQ) score, CDAI score, biological markers of inflammation (CRP and ESR), number of fistulas (including new fistulas and closure of existing ones), and antibodies to interferon beta-1a.

Interventions

Interferon beta-1aDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study

You may not qualify if:

  • Any other treatment for the maintenance of remission of Crohn's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medical Information Office

Munich, Germany

Location

Medical Information Office

Roma, Italy

Location

Medical Information Office

Solna, Sweden

Location

Medical Information Office

Zug, Switzerland

Location

Medical Information Office

Feltham, United Kingdom

Location

Related Publications (1)

  • Pena Rossi C, Hanauer SB, Tomasevic R, Hunter JO, Shafran I, Graffner H. Interferon beta-1a for the maintenance of remission in patients with Crohn's disease: results of a phase II dose-finding study. BMC Gastroenterol. 2009 Mar 20;9:22. doi: 10.1186/1471-230X-9-22.

    PMID: 19302707DERIVED

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Claudia Pena Rossi, M.D.

    EMD Serono

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 17, 2006

Study Start

November 1, 2001

Study Completion

September 1, 2003

Last Updated

August 6, 2013

Record last verified: 2013-08

Locations

IT(1)SE(1)GB(1)CH(1)DE(1)