Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice

NCT02251860 | Completed

• 1 other identifier: ML29087
• Study Type: observational
• Target: 1,454
• Locations: 1 country
• Sites: 1

Brief Summary

ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis in daily clinical practice. Participants will be followed over an observation period of up to 2 years after the initial injection.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Clinical Remission Defined by Disease Activity Score based on 28 Joints-Erythrocyte Sedimentation Rate (DAS28-ESR) in Participants with Previous Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) Treatment

  Up to Week 104

• Percentage of Participants with Clinical Remission Defined by DAS28-ESR in bDMARD Naïve Participants

  Up to Week 104

Secondary Outcomes (28)

• Change from Baseline in Mean DAS28-ESR Score

  Baseline up to Week 104

• Percentage of Participants with Continuation of Tocilizumab

  Up to Week 104

• Mean Retention Time of Tocilizumab

  Up to Week 104

• Percentage of Participants with Adverse Events (AEs) During Tocilizumab Treatment

  From Baseline up to tocilizumab treatment discontinuation (Up to Week 104)

• Percentage of Participants with Concomitant Treatment with Methotrexate (MTX)

  Up to Week 104

Study Arms (1)

Participants with Rheumatoid Arthritis

Participants with active rheumatoid arthritis who are prescribed tocilizumab treatment according to the marketing authorization by their physician will be followed under routine conditions over an observation period of up to 2 years if baseline and disease characteristics data are available.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with active rheumatoid arthritis who are prescribed subcutaneous tocilizumab treatment by their physician prior to and independent of the inclusion of the participant into the study. Participant can be enrolled into the study at maximum 1 month after first tocilizumab administration if baseline and disease characteristics data are available.

You may qualify if:

• Participants who have not yet been treated with tocilizumab

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Chugai Pharma Europe Ltd.: collaborator

Study Sites (1)

CIRI - Centrum für Innovative Diagnostik und Therapie Rheumatologie/ Immunologie (GmbH)

Frankfurt, 60528, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: May 20, 2014
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

DE (1)