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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01384461
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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).

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 251 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Efficacy: Disease Activity Score (DAS 28) [ Time Frame: 12 months ]
  2. Pain: Visual Analogue Scale (VAS) pain scale [ Time Frame: 12 months ]
  3. Physical Function: Health Assessments Questionnaire (HAQ) [ Time Frame: 12 months ]
  4. Incidence of patients with all-cause discontinuation of tocilizumab [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01384461

Budapest, Hungary, 1023
Budapest, Hungary, 1027
Budapest, Hungary, 1062
Debrecen, Hungary, 4032
Debrecen, Hungary, 4043
Eger, Hungary, 3300
Esztergom, Hungary, 2500
Gyula, Hungary, 5700
Győr, Hungary, 9023
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

Responsible Party: Hoffmann-La Roche Identifier: NCT01384461     History of Changes
Other Study ID Numbers: ML25503
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors