NCT01672970

Brief Summary

This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

20 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 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 28, 2016

Completed
Last Updated

March 28, 2016

Status Verified

February 1, 2016

Enrollment Period

2.5 years

First QC Date

August 22, 2012

Results QC Date

January 28, 2016

Last Update Submit

February 29, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (32)

  • Percentage of Participants With Systemic Manifestations of RA at Baseline

    Baseline

  • Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline

    Prior to study (8 weeks) to Baseline

  • Percentage of Participants With Reason for DMARDs Withdrawal at Baseline

    Baseline

  • Number of Previous Biologic RA Treatments Received by Participants

    Baseline

  • Percentage of Participants With Duration of Previous Biologic RA Treatments

    Baseline

  • +27 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 rheumatoid arthritis initiated on treatment with RoActemra/Actemra (tocilizumab)

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit

You may not qualify if:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Patients who have previously received RoActemra/Actemra 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 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 (20)

Unknown Facility

Budapest, 1023, Hungary

Location

Unknown Facility

Budapest, 1027, Hungary

Location

Unknown Facility

Budapest, 1062, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Debrecen, 4043, Hungary

Location

Unknown Facility

Eger, 3300, Hungary

Location

Unknown Facility

Esztergom, 2500, Hungary

Location

Unknown Facility

Győr, 9004, Hungary

Location

Unknown Facility

Gyula, 5700, Hungary

Location

Unknown Facility

Hévíz, 8380, Hungary

Location

Unknown Facility

Kecskemét, 6000, Hungary

Location

Unknown Facility

Kistarcsa, 2143, Hungary

Location

Unknown Facility

Miskolc, 3529, Hungary

Location

Unknown Facility

Nyíregyháza, 4400, Hungary

Location

Unknown Facility

Pécs, 7632, Hungary

Location

Unknown Facility

Szeged, 6724, Hungary

Location

Unknown Facility

Székesfehérvár, 8000, Hungary

Location

Unknown Facility

Szolnok, 5000, Hungary

Location

Unknown Facility

Szombathely, 9700, Hungary

Location

Unknown Facility

Veszprém, 8200, Hungary

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-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

August 22, 2012

First Posted

August 27, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 28, 2016

Results First Posted

March 28, 2016

Record last verified: 2016-02

Locations

HU(20)