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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01384461
First received: June 28, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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: 252
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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

Patients with moderate to severe rheumatoid arthritis initiated on treatment with RoActemra/Actemra in combination with methotrexate

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384461

Locations
Hungary
Budapest, Hungary, 1027
Budapest, Hungary, 1062
Budapest, Hungary, 1023
Debrecen, Hungary, 4043
Debrecen, Hungary, 4032
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01384461     History of Changes
Other Study ID Numbers: ML25503
Study First Received: June 28, 2011
Last Updated: May 23, 2013
Health Authority: Hungary: ETT Elnökség (Medical Research Council - Presidency)

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

ClinicalTrials.gov processed this record on May 23, 2013