NCT01770834

Brief Summary

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
4 countries

12 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

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

3.8 years

First QC Date

January 16, 2013

Last Update Submit

February 28, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    approximately 3 years

Secondary Outcomes (3)

  • Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)

    approximately 3 years

  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment

    approximately 3 years

  • Treatment regimens: Concomitant medications

    approximately 3 years

Study Arms (1)

Cohort

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs

You may qualify if:

  • Adult patients, \>/= 21 years of age
  • Moderate to severe active rheumatoid arthritis (DAS28 \>/= 3.2)
  • Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
  • Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

You may not qualify if:

  • Pregnant or lactating women
  • Contra-indication to RoActemra/Actemra treatment according to the local labelling
  • Previous treatment with tocilizumab
  • 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
  • Women of childbearing potential not using effective methods of contraception as defined by protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Safat, 13041, Kuwait

Location

Unknown Facility

Beirut, 11-236, Lebanon

Location

Unknown Facility

Beirut, 470 Hazmieh, Lebanon

Location

Unknown Facility

Beirut, 961, Lebanon

Location

Unknown Facility

Beirut, 99999, Lebanon

Location

Unknown Facility

Beirut, Lebanon

Location

Unknown Facility

Byblos, 1401, Lebanon

Location

Unknown Facility

Saida, 652, Lebanon

Location

Unknown Facility

Tripoli, 371 Tripoli, Lebanon

Location

Unknown Facility

Doha, 3050, Qatar

Location

Unknown Facility

Dubai, P.O. Box 31500, United Arab Emirates

Location

Unknown Facility

Dubai, P.O. Box 8179, United Arab Emirates

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

January 16, 2013

First Posted

January 18, 2013

Study Start

April 18, 2013

Primary Completion

January 25, 2017

Study Completion

January 25, 2017

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

KU(1)LE(8)QA(1)AE(2)