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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 15, 2011
Last updated: May 4, 2016
Last verified: May 2016
This prospective, multi-center, observational study will evaluate factors influencing the use of RoActemra/Actemra (tocilizumab) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from patients for 12 months following initiation of RoActemra treatment.

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
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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 identifier: NCT01474291

  Show 119 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01474291     History of Changes
Other Study ID Numbers: ML27873 
Study First Received: November 15, 2011
Last Updated: May 4, 2016
Health Authority: France: Commission Nationale de l'Informatique rt des Libertés (CNIL)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on July 27, 2016