An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice (ACT-SOLO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01474291
First received: November 15, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This prospective, multi-center, observational study will evaluate factors influe ncing the use of RoActemra/Actemra (tocilizumab) as monotherapy in rheumatoid ar thritis patients in real life setting. Data will be collected from patients for 12 months following initiation of RoActemra treatment.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Factors Influencing Use of RoActemra as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correlation of patient/physician factors with monotherapy/combination therapy [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dosage/regimen one year after initiation of RoActemra/Actemra treatment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Disease Activity DAS28/SJC/TJC/VAS [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Quality of life: PASS/EULAR-RAID questionnaires [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 608
Study Start Date: February 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 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

Moderate to severe rheumatoid arthritis patients treated with RoActemra/Actemra in routine clinical practice

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with rheumatoid arthritis for whom the rheumatologist decides to start RoActemra/Actemra in combination with DMARD or as monotherapy

Exclusion Criteria:

  • Current participation in a clinical trial in 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: NCT01474291

  Show 119 Study Locations
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: NCT01474291     History of Changes
Other Study ID Numbers: ML27873
Study First Received: November 15, 2011
Last Updated: July 7, 2014
Health Authority: France: Commission Nationale de l'Informatique rt des Libertés (CNIL)

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 July 29, 2014