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.
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
199
Incidence of Tuberculosis infection or reactivation during the study
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)
Time frame: From Baseline to Week 156 (Visit 7)
Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 26
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.
Time frame: 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
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.
Time frame: 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
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.
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12
Kazan', Russia
16
Kazan', Russia
11
Moscow, Russia
14
Moscow, Russia
24
Moscow, Russia
25
Moscow, Russia
31
Moscow, Russia
34
Moscow, Russia
36
Moscow, Russia
40
Moscow, Russia
...and 35 more locations
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: From Baseline to Week 156 (Visit 7)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 26
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)
Time frame: From Baseline to Week 26 (Visit 2)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 52
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)
Time frame: From Baseline to Week 52 (Visit 3)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 78
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)
Time frame: From Baseline to Week 78 (Visit 4)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 104
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)
Time frame: From Baseline to Week 104 (Visit 5)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 130
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)
Time frame: From Baseline to Week 130 (Visit 6)
Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 156
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)
Time frame: From Baseline to Week 156 (Visit 7)
Incidence of Adverse Events during the study
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.
Time frame: From Baseline to Week 156 (Visit 7)