Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis
NCT ID: NCT01443364
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2011-12-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Certolizumab pegol
Certolizumab pegol
Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.
Interventions
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Certolizumab pegol
Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
* active RA disease
* subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
* subject is naïve to RA related biologics
Exclusion Criteria
* history of infected joint prosthesis, or other significant infection
* known Tuberculosis (TB) disease or high risk of acquiring TB infection
18 Years
ALL
No
Sponsors
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UCB Italy s.p.a.
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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11
Bari, , Italy
08
Catania, , Italy
10
Ferrara, , Italy
12
Florence, , Italy
01
Iesi, , Italy
05
Milan, , Italy
13
Milan, , Italy
18
Milan, , Italy
07
Modena, , Italy
23
Monserrato, , Italy
20
Napoli, , Italy
16
Padua, , Italy
06
Roma, , Italy
21
Roma, , Italy
22
Siena, , Italy
09
Torino, , Italy
04
Udine, , Italy
02
Verona, , Italy
Countries
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References
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Sarzi-Puttini P, Filippucci E, Adami S, Meroni PL, Batticciotto A, Idolazzi L, De Lucia O, Talavera P, Kumke T, Grassi W. Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results from the CZP-SPEED Study. Adv Ther. 2018 Aug;35(8):1153-1168. doi: 10.1007/s12325-018-0751-8. Epub 2018 Jul 24.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2011-000385-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RA0069
Identifier Type: -
Identifier Source: org_study_id
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