Observation of Treatment With Certolizumab Pegol in Daily Practice (FasT)
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|ClinicalTrials.gov Identifier: NCT01069419|
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : September 29, 2015
Last Update Posted : October 29, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1117 participants|
|Official Title:||A Multicenter, Observational, Non-interventional Study to Evaluate the Safety and Efficacy of Anti-TNF (Anti-Tumor Necrosis Factor) Alpha Therapy With Certolizumab Pegol Observed in Daily Practice in Adult Rheumatoid Arthritis (RA) Patients|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
- Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6 [ Time Frame: From Baseline to Visit 9 (around Week 104) ]
The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints.
For the analysis, DAS28 values were categorized into the following groups:
- DAS28 < 2.6: clinical remission
- DAS28 from 2.6 to ≤ 3.2: low disease activity
- DAS28 from > 3.2 to 5.1: moderate disease activity
- DAS28 > 5.1: high disease activity
- Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS) [ Time Frame: From Baseline to Visit 9 (around Week 104) ]Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
- Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: From Baseline to Visit 9 (around Week 104) ]The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
- Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI) [ Time Frame: From Baseline to Visit 9 (around Week 104) ]
The CDAI was calculated with the equation:
CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069419
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|Study Director:||UCB Clinical Trial Call center||+1 877 822 9493 (UCB)|