Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients
NCT ID: NCT01288287
Last Updated: 2016-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
149 participants
OBSERVATIONAL
2011-07-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Week 12 Disease Activity Score (DAS) Responders
Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12
No interventions assigned to this group
Week 12 Disease Activity Score (DAS) Non-Responders
Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) \[DAS28(ESR)\] score of greater than 1.2 points at Week 12
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The patient is considered capable of and prepared to adhere to the study protocol procedures
* The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA).
* The patient is screen-negative for tuberculosis
* The patient is 18 years of age or above
Exclusion Criteria
* Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA.
* Patient has participated in another study within the last 30 days
* Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study
* Patient has inadequate literacy to understand and complete the questionnaires.
* Contraindications stated in the SmPC
* Patient is pregnant or breast feeding
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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2
Cork, Cork, Ireland
7
Bridgend, Bridgend, United Kingdom
25
Cardiff, Cardiff, United Kingdom
4
Durham, County Durham, United Kingdom
17
Poole, Dorset, United Kingdom
24
Eastbourne, East Sussex, United Kingdom
13
Southend, Essex, United Kingdom
11
Manchester, Greater Manchester, United Kingdom
12
Manchester, Greater Manchester, United Kingdom
6
Southampton, Hampshire, United Kingdom
20
Gillingham, Kent, United Kingdom
15
St Helens, Lancashire, United Kingdom
10
Liverpool, Merseyside, United Kingdom
22
Ashford, Middlesex, United Kingdom
14
Abergavenny, Monmouthshire, United Kingdom
5
Bath, Somerset, United Kingdom
19
Burton, Staffordshire, United Kingdom
3
Chertsey, Surrey, United Kingdom
18
Birmingham, West Midlands, United Kingdom
16
Cannock, West Midlands, United Kingdom
9
Dudley, West Midlands, United Kingdom
1
York, Yorkshire, United Kingdom
Countries
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References
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Kumar N, Naz S, Quinn M, Ryan J, Kumke T, Sheeran T. Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland. Adv Ther. 2018 Sep;35(9):1426-1437. doi: 10.1007/s12325-018-0758-1. Epub 2018 Aug 3.
Other Identifiers
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RA0042
Identifier Type: -
Identifier Source: org_study_id
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