NCT01671059

Brief Summary

This non-interventional study evaluated the use and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment according to the approved label were followed for 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 2, 2016

Completed
Last Updated

February 23, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

August 20, 2012

Results QC Date

October 7, 2016

Last Update Submit

January 6, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation

    6 months

Secondary Outcomes (19)

  • Percentage of Participants With Dose Modifications

    6 months

  • Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

    6 months

  • Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents

    Baseline

  • Reasons for Dose Modifications

    6 months

  • Percentage of Participants With Dose Interruptions

    6 months

  • +14 more secondary outcomes

Study Arms (1)

Tocilizumab

Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.

Eligibility Criteria

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

Participants with rheumatoid arthritis initiated on treatment with tocilizumab (RoActemra/Actemra)

You may qualify if:

  • Adult participants, \>/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
  • Participants in whom the treating physician made the decision to commence tocilizumab treatment (in accordance with the local label); this could include participants who had received tocilizumab treatment within 8 weeks prior to the enrollment visit

You may not qualify if:

  • Participants who had received tocilizumab more than 8 weeks prior to the enrollment visit
  • Participants who had previously received tocilizumab in a clinical trial or for compassionate use
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever was longer) before starting treatment with tocilizumab
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Institut Za Reumatologiju; Reumatologiju

Belgrade, 11000, Serbia

Location

Military Medical Academy; Clinic of Rheumatology

Belgrade, 11000, Serbia

Location

Unknown Facility

Belgrade, 11000, Serbia

Location

Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

Niška Banja, 18205, Serbia

Location

Unknown Facility

Niška Banja, 18205, Serbia

Location

Clinical Center Voivodina; Clinic for Immunology and Nephrology

Novi Sad, 21000, Serbia

Location

Special hospital for rheumatic diseases Novi Sad

Novi Sad, 21000, Serbia

Location

Unknown Facility

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 23, 2017

Results First Posted

December 2, 2016

Record last verified: 2017-01

Locations

SE(8)