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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01069419
First received: February 15, 2010
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Remission after two years measured by reaching a Disease Activity Score 28 (DAS28) of < 2.6 [ Time Frame: From baseline to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to endpoint after two years in patients's arthritis pain as measured by Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) [ Time Frame: From baseline to 2 years ] [ Designated as safety issue: No ]
  • Change from Baseline to endpoint after two years in patient's physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: From baseline to 2 years ] [ Designated as safety issue: No ]
  • Change from Baseline to endpoint after two years in disease activity measured by Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline to 2 years ] [ Designated as safety issue: No ]

Enrollment: 1117
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069419

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

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01069419     History of Changes
Other Study ID Numbers: RA0027
Study First Received: February 15, 2010
Last Updated: May 22, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by UCB, Inc.:
Certolizumab Pegol
Cimzia

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013