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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 15, 2011
Last updated: April 7, 2014
Last verified: April 2014

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
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

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
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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01474291     History of Changes
Other Study ID Numbers: ML27873
Study First Received: November 15, 2011
Last Updated: April 7, 2014
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 April 17, 2014