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

November 1, 2016 updated by: Hoffmann-La Roche

An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1062
      • Budapest, Hungary, 1027
      • Budapest, Hungary, 1023
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Disease Activity Score (DAS 28)
Time Frame: 12 months
12 months
Pain: Visual Analogue Scale (VAS) pain scale
Time Frame: 12 months
12 months
Physical Function: Health Assessments Questionnaire (HAQ)
Time Frame: 12 months
12 months
Incidence of patients with all-cause discontinuation of tocilizumab
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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