A Non-Interventional Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01672970
First received: August 22, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiate d on RoActemra/Actemra treatment according to the local label will be followed f or 6 months.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With Tocilizumab.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients on RoActemra/Actemra at 6 months [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of dose modifications/interruptions [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Efficacy: Monotherapy versus combination therapy [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Use of disease-modifying anti-rheumatic drugs (DMARDs) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  Eligibility

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 rheumatoid arthritis initiated on treatment with RoActemra/Actemra (tocilizumab)

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit

Exclusion Criteria:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
  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: NCT01672970

Locations
Hungary
Budapest, Hungary, 1027
Budapest, Hungary, 1023
Budapest, Hungary, 1062
Debrecen, Hungary, 4032
Debrecen, Hungary, 4043
Eger, Hungary, 3300
Esztergom, Hungary, 2500
Gyor, Hungary, 9004
Gyula, Hungary, 5700
Heviz, Hungary, 8380
Kecskemet, Hungary, 6000
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3529
Nyiregyhaza, Hungary, 4400
Pécs, Hungary, 7632
Szeged, Hungary, 6724
Szekesfehervar, Hungary, 8000
Szolnok, Hungary, 5000
Szombathely, Hungary, 9700
Veszprem, Hungary, 8200
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01672970     History of Changes
Other Study ID Numbers: ML28212
Study First Received: August 22, 2012
Last Updated: August 4, 2014
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014