Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)

November 9, 2015 updated by: UCB Pharma

Observational Study to Evaluate the Safety and Effectiveness of Cimzia in Rheumatoid Arthritis and Crohn's Disease Patients When Using a Comprehensive Program of Tuberculosis Screening and Monitoring

This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.

Study Overview

Status

Terminated

Conditions

Detailed Description

This is a prospective non interventional study. Patients enrolled in this study will receive Cimzia on prescription according to the instructions for use approved in Russia and within the frame of current standard clinical practices. The patient is evaluated at the Screening Visit for enrollment. A Baseline Visit is to be scheduled no more than 28 days after the Screening Visit. Subsequent evaluations are done routinely every 6 months.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ekaterinburg, Russian Federation
        • 13
      • Ekaterinburg, Russian Federation
        • 28
      • Kazan, Russian Federation
        • 12
      • Kazan, Russian Federation
        • 16
      • Moscow, Russian Federation
        • 11
      • Moscow, Russian Federation
        • 14
      • Moscow, Russian Federation
        • 24
      • Moscow, Russian Federation
        • 25
      • Moscow, Russian Federation
        • 31
      • Moscow, Russian Federation
        • 34
      • Moscow, Russian Federation
        • 36
      • Moscow, Russian Federation
        • 40
      • Moscow, Russian Federation
        • 42
      • Moscow, Russian Federation
        • 45
      • Moscow, Russian Federation
        • 5
      • Moscow, Russian Federation
        • 7
      • Moscow, Russian Federation
        • 8
      • Moscow, Russian Federation
        • 9
      • Novgorod, Russian Federation
        • 23
      • Orenburg, Russian Federation
        • 20
      • Orenburg, Russian Federation
        • 21
      • Orenburg, Russian Federation
        • 29
      • Perm, Russian Federation
        • 43
      • Petrozavodzk, Russian Federation
        • 39
      • Saint Petersburg, Russian Federation
        • 1
      • Saint Petersburg, Russian Federation
        • 3
      • Saint Petersburg, Russian Federation
        • 4
      • Saint Petersburg, Russian Federation
        • 6
      • Samara, Russian Federation
        • 15
      • Samara, Russian Federation
        • 18
      • Samara, Russian Federation
        • 41
      • Saratow, Russian Federation
        • 33
      • Shakhty, Russian Federation
        • 17
      • St. Petersburg, Russian Federation
        • 19
      • Taganrog, Russian Federation
        • 10
      • Tolyatti, Russian Federation
        • 26
      • Ufa, Russian Federation
        • 22
      • Ufa, Russian Federation
        • 27
      • Ufa, Russian Federation
        • 32
      • Ufa, Russian Federation
        • 35
      • Ufa, Russian Federation
        • 37
      • Ufa, Russian Federation
        • 38
      • Ufa, Russian Federation
        • 55
      • Ulyanovsk, Russian Federation
        • 30
      • Yaroslavl, Russian Federation
        • 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from previous UCB sponsored studies and all patients for whom the treating physician prescribed Cimzia.

Description

Inclusion Criteria:

  • Patients who have been prescribed Cimzia

Exclusion Criteria:

  • Any contra-indication according to the Russian Summary of Product Characteristic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cimzia treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Tuberculosis infection or reactivation during the study
Time Frame: From Baseline to Week 156 (Visit 7)
The incidence of Tuberculosis (TB) infection or reactivation is assessed by routine TB diagnostic tests (Chest X-ray, skin test, Interferon-γ-release assays recognizing antigens representing 2 Mycobacterium tuberculosis proteins (preferably both blood and skin tests), ESAT-6 and CFP-10)
From Baseline to Week 156 (Visit 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 26
Time Frame: From Baseline to Week 26 (Visit 2)
DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.
From Baseline to Week 26 (Visit 2)
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 52
Time Frame: From Baseline to Week 52 (Visit 3)
DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.
From Baseline to Week 52 (Visit 3)
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 78
Time Frame: From Baseline to Week 78 (Visit 4)
DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.
From Baseline to Week 78 (Visit 4)
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 104
Time Frame: From Baseline to Week 104 (Visit 5)
DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.
From Baseline to Week 104 (Visit 5)
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 130
Time Frame: From Baseline to Week 130 (Visit 6)
DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.
From Baseline to Week 130 (Visit 6)
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 156
Time Frame: From Baseline to Week 156 (Visit 7)
DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.
From Baseline to Week 156 (Visit 7)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 26
Time Frame: From Baseline to Week 26 (Visit 2)

The HBI (Harvey and Bradshaw, 1980) will be calculated for all CD patients and is composed of 5 items:

General well-being (0=Very well, 1=Slightly below Par, 2=Poor, 3=Very poor, 4=Terrible) Abdominal pain (0=None, 1=Mild, 2=Moderate, 3=Severe) Number of liquid stools per day Abdominal mass (0=None, 1=Dubious, 2=Definite, 3=Definite and tender) Complications (1 per item: Arthralgia, Uveitis, Erythema nodosum, Aphthous ulcers, Pyoderma gangrenosum, Anal fissure, New fistula, and Abscess)
From Baseline to Week 26 (Visit 2)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 52
Time Frame: From Baseline to Week 52 (Visit 3)

The HBI (Harvey and Bradshaw, 1980) will be calculated for all CD patients and is composed of 5 items:

General well-being (0=Very well, 1=Slightly below Par, 2=Poor, 3=Very poor, 4=Terrible) Abdominal pain (0=None, 1=Mild, 2=Moderate, 3=Severe) Number of liquid stools per day Abdominal mass (0=None, 1=Dubious, 2=Definite, 3=Definite and tender) Complications (1 per item: Arthralgia, Uveitis, Erythema nodosum, Aphthous ulcers, Pyoderma gangrenosum, Anal fissure, New fistula, and Abscess)
From Baseline to Week 52 (Visit 3)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 78
Time Frame: From Baseline to Week 78 (Visit 4)

The HBI (Harvey and Bradshaw, 1980) will be calculated for all CD patients and is composed of 5 items:

General well-being (0=Very well, 1=Slightly below Par, 2=Poor, 3=Very poor, 4=Terrible) Abdominal pain (0=None, 1=Mild, 2=Moderate, 3=Severe) Number of liquid stools per day Abdominal mass (0=None, 1=Dubious, 2=Definite, 3=Definite and tender) Complications (1 per item: Arthralgia, Uveitis, Erythema nodosum, Aphthous ulcers, Pyoderma gangrenosum, Anal fissure, New fistula, and Abscess)
From Baseline to Week 78 (Visit 4)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 104
Time Frame: From Baseline to Week 104 (Visit 5)

The HBI (Harvey and Bradshaw, 1980) will be calculated for all CD patients and is composed of 5 items:

General well-being (0=Very well, 1=Slightly below Par, 2=Poor, 3=Very poor, 4=Terrible) Abdominal pain (0=None, 1=Mild, 2=Moderate, 3=Severe) Number of liquid stools per day Abdominal mass (0=None, 1=Dubious, 2=Definite, 3=Definite and tender) Complications (1 per item: Arthralgia, Uveitis, Erythema nodosum, Aphthous ulcers, Pyoderma gangrenosum, Anal fissure, New fistula, and Abscess)
From Baseline to Week 104 (Visit 5)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 130
Time Frame: From Baseline to Week 130 (Visit 6)

The HBI (Harvey and Bradshaw, 1980) will be calculated for all CD patients and is composed of 5 items:

General well-being (0=Very well, 1=Slightly below Par, 2=Poor, 3=Very poor, 4=Terrible) Abdominal pain (0=None, 1=Mild, 2=Moderate, 3=Severe) Number of liquid stools per day Abdominal mass (0=None, 1=Dubious, 2=Definite, 3=Definite and tender) Complications (1 per item: Arthralgia, Uveitis, Erythema nodosum, Aphthous ulcers, Pyoderma gangrenosum, Anal fissure, New fistula, and Abscess)
From Baseline to Week 130 (Visit 6)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 156
Time Frame: From Baseline to Week 156 (Visit 7)

The HBI (Harvey and Bradshaw, 1980) will be calculated for all CD patients and is composed of 5 items:

General well-being (0=Very well, 1=Slightly below Par, 2=Poor, 3=Very poor, 4=Terrible) Abdominal pain (0=None, 1=Mild, 2=Moderate, 3=Severe) Number of liquid stools per day Abdominal mass (0=None, 1=Dubious, 2=Definite, 3=Definite and tender) Complications (1 per item: Arthralgia, Uveitis, Erythema nodosum, Aphthous ulcers, Pyoderma gangrenosum, Anal fissure, New fistula, and Abscess)
From Baseline to Week 156 (Visit 7)
Incidence of Adverse Events during the study
Time Frame: From Baseline to Week 156 (Visit 7)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Baseline to Week 156 (Visit 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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