Observation of Treatment With Certolizumab Pegol in Daily Practice (FasT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01069419
First received: February 15, 2010
Last updated: October 6, 2015
Last verified: October 2015
  Purpose
This is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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).



Enrollment: 1117
Study Start Date: October 2009
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cimzia
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC

Detailed Description:
The purpose of this study is to assess the clinical efficacy of Cimzia in achieving clinical remission after two years of therapy. The observational nature of the study leaves the therapeutic decision exclusively within the discretion of the treating physician.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female ≥ 18 years of age with RA and is eligible for treatment with Cimzia. Recruited in Germany.
Criteria

Inclusion Criteria:

  • Patients eligible for treatment with Cimzia as defined in EU approved SmPC

Exclusion Criteria:

  • Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069419

  Show 163 Study Locations
Sponsors and Collaborators
UCB Pharma GmbH
Investigators
Study Director: UCB Clinical Trial Call center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: UCB Pharma GmbH
ClinicalTrials.gov Identifier: NCT01069419     History of Changes
Other Study ID Numbers: RA0027 
Study First Received: February 15, 2010
Results First Received: August 27, 2015
Last Updated: October 6, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by UCB Pharma:
Certolizumab Pegol
Cimzia

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 21, 2016