Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)

NCT ID: NCT00329420

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-05-31

Brief Summary

This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.

Detailed Description

This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 (NCT00291668). All 'Week' numbers quoted are relative to the start of the double-blind main study. The first visit in this extension study is at Week 8, and the final efficacy assessment in this extension study, 26 weeks later, is at Week 34.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CZP 400 mg / Placebo

Certolizumab pegol (CZP) 400 mg in this extension study / Placebo in double-blind main study (NCT00291668)

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: BIOLOGICAL

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.

CZP 400 mg / CZP 200 mg

Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 200 mg in double-blind main study (NCT00291668)

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: BIOLOGICAL

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.

CZP 400 mg / CZP 400 mg

Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 400 mg in double-blind main study (NCT00291668)

Group Type: EXPERIMENTAL

Certolizumab pegol

Intervention Type: BIOLOGICAL

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.

Interventions

Certolizumab pegol

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.

Intervention Type: BIOLOGICAL

Certolizumab pegol

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.

Intervention Type: BIOLOGICAL

Certolizumab pegol

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.

Intervention Type: BIOLOGICAL

Other Intervention Names

CDP870; Cimzia; CZP; CDP870; Cimzia; CZP; CDP870; Cimzia; CZP

Eligibility Criteria

Inclusion Criteria

• Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) [reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)]

Exclusion Criteria

• Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Aichi-Gun, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Toyoake, Aichi-ken, Japan

Toyohashi, Aichi-ken, Japan

Kashiwa, Chiba, Japan

Sakura, Chiba, Japan

Chikusino, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Asahikawa, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Nishinomiya, Hyōgo, Japan

Kagoshima, Kagoshima-ken, Japan

Yokohama, Kanagawa, Japan

Miyazaki-gun, Miyazaki, Japan

Nagasaki, Nagasaki, Japan

Niigata, Niigata, Japan

Kurashiki, Okayama-ken, Japan

Tyuto-gun, Okianawa, Japan

Osaka, Osaka, Japan

Osaka Suita, Osaka, Japan

Shiga Otsu, Shiga, Japan

Shinjyuku/Tokyo, Tokyo, Japan

Shinjyuku, Tokyo, Japan

Countries

Japan

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2014-004400-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C87048

Identifier Type: -

Identifier Source: org_study_id