NCT01194401

Brief Summary

This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,404

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

First QC Date

September 1, 2010

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6

    5 years

Secondary Outcomes (8)

  • Time to DAS28 remission

    5 years

  • Proportion of patients with good or moderate response according to EULAR criteria

    5 years

  • Time to good or moderate response according to EULAR criteria

    5 years

  • Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness)

    5 years

  • Dose-modifications and discontinuations of RoActemra/Actemra

    5 years

  • +3 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with inadequate response or intolerant to DMARDs and anti-TNF

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Active moderate to severe rheumatoid arthritis
  • Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists
  • Prescription of RoActemra/Actemra according to label

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Osnabrück, 49074, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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 1, 2010

First Posted

September 3, 2010

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(1)