An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 28, 2011
Last updated: May 4, 2016
Last verified: May 2016
This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Disease Activity Score (DAS 28) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pain: Visual Analogue Scale (VAS) pain scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical Function: Health Assessments Questionnaire (HAQ) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of patients with all-cause discontinuation of tocilizumab [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: May 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 initiated on treatment with RoActemra/Actemra in combination with methotrexate

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
  • Active, severe infection or history of recurrent clinically significant infection
  • Pregnancy
  • Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
  • Methotrexate intolerance
  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: NCT01384461

Budapest, Hungary, 1023
Budapest, Hungary, 1027
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
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01384461     History of Changes
Other Study ID Numbers: ML25503 
Study First Received: June 28, 2011
Last Updated: May 4, 2016
Health Authority: Hungary: ETT Elnökség (Medical Research Council - Presidency)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 26, 2016