A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)

NCT ID: NCT01649817

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

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

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 multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.

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

RETROSPECTIVE

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 according to the revised 1987 ACR criteria at baseline
* RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
* Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis

Exclusion Criteria

* Rheumatic autoimmune disease other than RA
* Participation in interventional clinical trials during the observational period
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.

Agios Dimitrios, , Greece

Site Status

AgĂ­a ParaskevĂ­, , Greece

Site Status

Argiroupoli, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Chalandri, , Greece

Site Status

Chania, , Greece

Site Status

Corinth, , Greece

Site Status

Eleusina, , Greece

Site Status

Herakleio, , Greece

Site Status

Ioannina, , Greece

Site Status

Kifissia, , Greece

Site Status

Peristeri, , Greece

Site Status

Peuki, , Greece

Site Status

Rethymno, , Greece

Site Status

Serres, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Volos, , Greece

Site Status

Countries

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

Greece

Other Identifiers

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

ML28258

Identifier Type: -

Identifier Source: org_study_id