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

NCT ID: NCT01384461

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

251 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Eger, , Hungary

Site Status

Esztergom, , Hungary

Site Status

Győr, , Hungary

Site Status

Gyula, , Hungary

Site Status

Hévíz, , Hungary

Site Status

Kecskemét, , Hungary

Site Status

Kistarcsa, , Hungary

Site Status

Miskolc, , Hungary

Site Status

Nyíregyháza, , Hungary

Site Status

Pécs, , Hungary

Site Status

Szeged, , Hungary

Site Status

Székesfehérvár, , Hungary

Site Status

Szolnok, , Hungary

Site Status

Szombathely, , Hungary

Site Status

Veszprém, , Hungary

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hungary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML25503

Identifier Type: -

Identifier Source: org_study_id