An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664117
First received: August 8, 2012
Last updated: October 6, 2014
Last verified: October 2014

August 8, 2012
October 6, 2014
June 2012
June 2013   (final data collection date for primary outcome measure)
Clinical and demographic patient characteristics in clinical practice at initiation of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01664117 on ClinicalTrials.gov Archive Site
  • Disease Activity Score 28 (DAS28) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy
Study of Clinical Management and Profile of Patients With Rheumatoid Arthritis Treated With Biological Therapies in Monotherapy

This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arth ritis receiving any biological therapies in monotherapy.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Patients with moderate to severe rheumatoid arthritis

Rheumatoid Arthritis
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs
  • Patients treated with biologic DMARDs alone for at least 6 months

Exclusion Criteria:

  • Patients not willing or unable to give written informed consent for participation in this study
  • Patients who are participating in any clinical trial at the time of this study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01664117
ML28356
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP