Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

UCB Pharma94 enrolled

Overview

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Crohn's Disease

Interventions

Certolizumab PegolBIOLOGICAL

* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use

PlaceboOTHER

* Active Substance: isotonic sodium chloride solution * Pharmaceutical Form: Solution for injection * Concentration: 1 mL * Route of Administration: Subcutaneous use

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria: * Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders \[Shimoyama group, January 25, 2002\]) at least 24 weeks before the starting date of the observation period * Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period * C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period Exclusion Criteria: * Stoma patient * Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody * Patients who participated in a clinical study with CDP870 * Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period * Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators Exclusion Criteria:

Locations (22)

Unnamed facility

Aichi-Gun, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Toyoake, Aichi-ken, Japan

Outcomes

Primary Outcomes

Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6

CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of \<= 150 at Week 6.

Time frame: Baseline, Week 6

Secondary Outcomes

Crohn's Disease Activity Index (CDAI) Score at Week 2

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Week 2

Crohn's Disease Activity Index (CDAI) Score at Week 4

Time frame: Week 4

Crohn's Disease Activity Index (CDAI) Score at Week 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Unnamed facility

Toyohashi, Aichi-ken, Japan

Unnamed facility

Kashiwa, Chiba, Japan

Unnamed facility

Sakura, Chiba, Japan

Unnamed facility

Chikusino, Fukuoka, Japan

Unnamed facility

Asahikawa, Hokkaido, Japan

Unnamed facility

Sapporo, Hokkaido, Japan

Unnamed facility

Nishinomiya, Hyōgo, Japan

...and 12 more locations

Percentage of Subjects Who Achieve CDAI Response at Week 2

CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of \<= 150 points.

Time frame: Baseline, Week 2

Percentage of Subjects Who Achieve CDAI Response at Week 4

CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of \<= 150 points.

Time frame: Baseline, Week 4

Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Baseline, Week 2

Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4

Time frame: Baseline, Week 4

Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6

Time frame: Baseline, Week 6

Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2

Remission at Week 2 is defined as a CDAI score \<= 150 points at Week 2.

Time frame: Week 2

Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4

Remission at Week 4 is defined as a CDAI score \<= 150 points at Week 4.

Time frame: Week 4

Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6

Remission at Week 6 is defined as a CDAI score \<= 150 points at Week 6.

Time frame: Week 6

Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2

Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).

Time frame: Baseline, Week 2

Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4

Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).

Time frame: Baseline, Week 4

Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6

Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).

Time frame: Baseline, Week 6

Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2

The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.

Time frame: Week 2

Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4

Time frame: Week 4

Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6

Time frame: Week 6

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2

The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: * Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) * Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) * Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) * Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )

Time frame: Week 2

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4

Time frame: Week 4

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6

Time frame: Week 6

Concentration of C-reactive Protein (CRP) Value at Week 2