Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)
- Conditions
- Rheumatoid ArthritisCrohn's Disease
- Registration Number
- NCT01577264
- Lead Sponsor
- UCB Pharma
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 199
- Patients who have been prescribed Cimzia
- Any contra-indication according to the Russian Summary of Product Characteristic
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Tuberculosis infection or reactivation during the study 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)
- Secondary Outcome Measures
Name Time Method Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 26 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.
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 52 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.
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 78 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.
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 104 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.
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 130 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.
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 156 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.
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 26 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)Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 52 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)Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 78 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)Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 104 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)Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 130 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)Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 156 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)Incidence of Adverse Events during the study 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.
Trial Locations
- Locations (45)
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
Scroll for more (35 remaining)13🇷🇺Ekaterinburg, Russian Federation