Clinical trial NCT01577264: Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Crohn's Disease
Keywords: Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from previous UCB sponsored studies and all patients for whom the treating physician prescribed Cimzia.

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.

Eligibility criteria: Inclusion Criteria:

* Patients who have been prescribed Cimzia

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of Tuberculosis infection or reactivation during the study
timeFrame: From Baseline to Week 156 (Visit 7)
Secondary outcomes:
measure: Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 26
timeFrame: From Baseline to Week 26 (Visit 2)
measure: Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 52
timeFrame: From Baseline to Week 52 (Visit 3)
measure: Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 78
timeFrame: From Baseline to Week 78 (Visit 4)
measure: Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 104
timeFrame: From Baseline to Week 104 (Visit 5)
measure: Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 130
timeFrame: From Baseline to Week 130 (Visit 6)
measure: Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 156
timeFrame: From Baseline to Week 156 (Visit 7)
measure: Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 26
timeFrame: From Baseline to Week 26 (Visit 2)
measure: Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 52
timeFrame: From Baseline to Week 52 (Visit 3)
measure: Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 78
timeFrame: From Baseline to Week 78 (Visit 4)
measure: Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 104
timeFrame: From Baseline to Week 104 (Visit 5)
measure: Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 130
timeFrame: From Baseline to Week 130 (Visit 6)
measure: Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 156
timeFrame: From Baseline to Week 156 (Visit 7)
measure: Incidence of Adverse Events during the study
timeFrame: From Baseline to Week 156 (Visit 7)
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: 13
city: Ekaterinburg
country: Russian Federation
facility: 28
city: Kazan
country: Russian Federation
facility: 12
city: Kazan
country: Russian Federation
facility: 16
city: Moscow
country: Russian Federation
facility: 11
city: Moscow
country: Russian Federation
facility: 14
city: Moscow
country: Russian Federation
facility: 24
city: Moscow
country: Russian Federation
facility: 25
city: Moscow
country: Russian Federation
facility: 31
city: Moscow
country: Russian Federation
facility: 34
city: Moscow
country: Russian Federation
facility: 36
city: Moscow
country: Russian Federation
facility: 40
city: Moscow
country: Russian Federation
facility: 42
city: Moscow
country: Russian Federation
facility: 45
city: Moscow
country: Russian Federation
facility: 5
city: Moscow
country: Russian Federation
facility: 7
city: Moscow
country: Russian Federation
facility: 8
city: Moscow
country: Russian Federation
facility: 9
city: Novgorod
country: Russian Federation
facility: 23
city: Orenburg
country: Russian Federation
facility: 20
city: Orenburg
country: Russian Federation
facility: 21
city: Orenburg
country: Russian Federation
facility: 29
city: Perm
country: Russian Federation
facility: 43
city: Petrozavodzk
country: Russian Federation
facility: 39
city: Saint Petersburg
country: Russian Federation
facility: 1
city: Saint Petersburg
country: Russian Federation
facility: 3
city: Saint Petersburg
country: Russian Federation
facility: 4
city: Saint Petersburg
country: Russian Federation
facility: 6
city: Samara
country: Russian Federation
facility: 15
city: Samara
country: Russian Federation
facility: 18
city: Samara
country: Russian Federation
facility: 41
city: Saratow
country: Russian Federation
facility: 33
city: Shakhty
country: Russian Federation
facility: 17
city: St. Petersburg
country: Russian Federation
facility: 19
city: Taganrog
country: Russian Federation
facility: 10
city: Tolyatti
country: Russian Federation
facility: 26
city: Ufa
country: Russian Federation
facility: 22
city: Ufa
country: Russian Federation
facility: 27
city: Ufa
country: Russian Federation
facility: 32
city: Ufa
country: Russian Federation
facility: 35
city: Ufa
country: Russian Federation
facility: 37
city: Ufa
country: Russian Federation
facility: 38
city: Ufa
country: Russian Federation
facility: 55
city: Ulyanovsk
country: Russian Federation
facility: 30
city: Yaroslavl
country: Russian Federation
facility: 2
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: