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

This study has been terminated.
(Study is replaced by some Risk Manag. Activities covering the whole Russian Federation. Primary objectives could not be met due to critical missing information.)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01577264
First received: April 11, 2012
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
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.

Condition
Rheumatoid Arthritis
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Incidence of Tuberculosis infection or reactivation during the study [ Time Frame: From Baseline to Week 156 (Visit 7) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]

    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)


  • 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) ] [ Designated as safety issue: No ]

    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)


  • 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) ] [ Designated as safety issue: No ]

    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)


  • 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) ] [ Designated as safety issue: No ]

    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)


  • 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) ] [ Designated as safety issue: No ]

    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)


  • 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) ] [ Designated as safety issue: No ]

    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)


  • Incidence of Adverse Events during the study [ Time Frame: From Baseline to Week 156 (Visit 7) ] [ Designated as safety issue: No ]
    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.


Enrollment: 199
Study Start Date: August 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cimzia treatment

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from previous UCB sponsored studies and all patients for whom the treating physician prescribed Cimzia.
Criteria

Inclusion Criteria:

  • Patients who have been prescribed Cimzia

Exclusion Criteria:

  • Any contra-indication according to the Russian Summary of Product Characteristic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577264

Locations
Russian Federation
13
Ekaterinburg, Russian Federation
28
Ekaterinburg, Russian Federation
12
Kazan, Russian Federation
16
Kazan, 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
9
Moscow, Russian Federation
7
Moscow, Russian Federation
8
Moscow, Russian Federation
5
Moscow, Russian Federation
23
Novgorod, Russian Federation
20
Orenburg, Russian Federation
21
Orenburg, Russian Federation
29
Orenburg, Russian Federation
43
Perm, Russian Federation
39
Petrozavodzk, Russian Federation
4
Saint Petersburg, Russian Federation
3
Saint Petersburg, Russian Federation
6
Saint Petersburg, Russian Federation
1
Saint Petersburg, Russian Federation
15
Samara, Russian Federation
18
Samara, Russian Federation
41
Samara, Russian Federation
33
Saratow, Russian Federation
17
Shakhty, Russian Federation
19
St. Petersburg, Russian Federation
10
Taganrog, Russian Federation
26
Tolyatti, Russian Federation
55
Ufa, Russian Federation
22
Ufa, Russian Federation
32
Ufa, Russian Federation
35
Ufa, Russian Federation
37
Ufa, Russian Federation
38
Ufa, Russian Federation
27
Ufa, Russian Federation
30
Ulyanovsk, Russian Federation
2
Yaroslavl, Russian Federation
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01577264     History of Changes
Other Study ID Numbers: RA0091 
Study First Received: April 11, 2012
Last Updated: November 9, 2015
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by UCB Pharma:
Certolizumab Pegol
Cimzia

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Crohn Disease
Autoimmune Diseases
Connective Tissue Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Certolizumab Pegol
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2016