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Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

NCT ID: NCT00329550

Last Updated: 2015-03-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-04-30

Brief Summary

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This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).

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Detailed Description

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In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study. The first visit in this extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being assessed at Week 26. All week numbers quoted are relative to the start of the double-blind main study.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 (CZP)

Intervention Type BIOLOGICAL

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 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 (CZP)

Intervention Type BIOLOGICAL

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 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 (CZP)

Intervention Type BIOLOGICAL

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

Interventions

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Certolizumab pegol (CZP)

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 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 (CZP)

Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 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 (CZP)

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

Intervention Type BIOLOGICAL

Other Intervention Names

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CDP870 Cimzia CZP CDP870 Cimzia CZP CDP870 Cimzia CZP

Eligibility Criteria

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Inclusion Criteria

* Subjects who participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy

Exclusion Criteria

* Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change
Minimum Eligible Age

16 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Japan Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: PRINCIPAL_INVESTIGATOR

+1 877 822 9493 (UCB)

Locations

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Aichi-Gun, Aichi-ken, Japan

Site Status

Nagoya, Aichi-ken, Japan

Site Status

Toyoake, Aichi-ken, Japan

Site Status

Toyohashi, Aichi-ken, Japan

Site Status

Kashiwa, Chiba, Japan

Site Status

Sakura, Chiba, Japan

Site Status

Chikusino, Fukuoka, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Asahikawa, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Nishinomiya, Hyōgo, Japan

Site Status

Kagoshima, Kagoshima-ken, Japan

Site Status

Yokohama, Kanagawa, Japan

Site Status

Miyazaki-Gun, Miyazaki, Japan

Site Status

Nagasaki, Nagasaki, Japan

Site Status

Niigata, Niigata, Japan

Site Status

Kurashiki, Okayama-ken, Japan

Site Status

Tyuto-gun, Okinawa, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Suita, Osaka, Japan

Site Status

Ōtsu, Shiga, Japan

Site Status

Shinjyuku/Tokyo, Tokyo, Japan

Site Status

Shinjyuku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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

FDA Safety Alerts and Recalls

Other Identifiers

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2014-004354-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C87047

Identifier Type: -

Identifier Source: org_study_id

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