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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 8, 2012
Last updated: December 1, 2015
Last verified: December 2015
This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of Clinical Management and Profile of Patients With Rheumatoid Arthritis Treated With Biological Therapies in Monotherapy

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Clinical and demographic patient characteristics in clinical practice at initiation of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 210
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe rheumatoid arthritis

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
  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 identifier: NCT01664117

Vitoria, Alava, Spain, 01009
Elche, Alicante, Spain, 03203
Oviedo, Asturias, Spain, 33006
Zafra, Badajoz, Spain, 06300
Sabadell, Barcelona, Spain, 08208
Viladecans, Barcelona, Spain, 08840
Jerez de la Frontera, Cadiz, Spain, 11407
Vinaroz, Castellon, Spain, 12500
Cenes de la vega, Granada, Spain, 18190
Granda, Granada, Spain, 18190
San Sebastian, Guipuzcoa, Spain, 20080
Ibiza, Islas Baleares, Spain, 07800
Inca, Islas Baleares, Spain, 07300
Manacor (Islas Baleares), Islas Baleares, Spain, 07500
Jaén, Jaen, Spain, 23007
La Coruna, La Coruña, Spain, 15006
Alcala de Henares, Madrid, Spain, 28805
Benalmadena, Malaga, Spain, 29630
Vigo, Pontevedra, Spain, 36214
Gandia, Valencia, Spain, 46700
Alicante, Spain, 03010
Burgos, Spain, 06006
Caceres, Spain, 10310
Cordoba, Spain, 14001
Girona, Spain, 17007
Madrid, Spain, 28034
Madrid, Spain, 28007
Madrid, Spain, 28222
Madrid, Spain, 28905
Madrid, Spain, 28006
Malaga, Spain, 29005
Murcia, Spain, 30008
Palencia, Spain, 34005
Sevilla, Spain, 41018
Sevilla, Spain, 41013
Tenerife, Spain, 38010
Toledo, Spain, 45004
Valencia, Spain, 46015
Valladolid, Spain, 47005
Zamora, Spain, 49022
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01664117     History of Changes
Other Study ID Numbers: ML28356 
Study First Received: August 8, 2012
Last Updated: December 1, 2015
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on February 11, 2016