NCT01579006

Brief Summary

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

14 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

First Submitted

Initial submission to the registry

April 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 14, 2016

Completed
Last Updated

March 7, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

April 16, 2012

Results QC Date

December 8, 2015

Last Update Submit

February 4, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation

    6 months

  • Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation

    5-6 months

Secondary Outcomes (34)

  • Percentage of Participants With Systemic Manifestations of RA at Baseline

    Baseline

  • Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study

    Prior to study start (8 weeks) and Baseline up to 6 months

  • Percentage of Participants With Reason for DMARD Withdrawal

    Up to 6 months

  • Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study

    Prior to study start (8 weeks)

  • Percentage of Participants With Type of Previous Biologic RA Treatments

    Up to 6 months

  • +29 more secondary outcomes

Study Arms (1)

Cohort

Drug: Tocilizumab

Interventions

TocilizumabDRUG
Also known as: Actemra
Cohort

Eligibility Criteria

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

Rheumatoid arthritis patients treated with tocilizumab

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
  • Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

You may not qualify if:

  • RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Afula, 18101, Israel

Location

Unknown Facility

Beer Yaakov, 6093000, Israel

Location

Unknown Facility

Beersheba, 8410101, Israel

Location

Unknown Facility

Hadera, 38100, Israel

Location

Unknown Facility

Haifa, 31048, Israel

Location

Unknown Facility

Haifa, 3109601, Israel

Location

Unknown Facility

Haifa, 34362, Israel

Location

Unknown Facility

Jerusalem, 9112001, Israel

Location

Unknown Facility

Jerusalem, 91240, Israel

Location

Unknown Facility

Kfar Saba, 44281, Israel

Location

Unknown Facility

Petah Tikva, 4937211, Israel

Location

Unknown Facility

Petah Tikva, 4941492, Israel

Location

Unknown Facility

Ramat Gan, 5262000, Israel

Location

Unknown Facility

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

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-LaRoche
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

April 16, 2012

First Posted

April 17, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 7, 2016

Results First Posted

January 14, 2016

Record last verified: 2016-02

Locations

IL(14)