NCT01384461

Brief Summary

This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

June 28, 2011

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    12 months

Secondary Outcomes (4)

  • Efficacy: Disease Activity Score (DAS 28)

    12 months

  • Pain: Visual Analogue Scale (VAS) pain scale

    12 months

  • Physical Function: Health Assessments Questionnaire (HAQ)

    12 months

  • Incidence of patients with all-cause discontinuation of tocilizumab

    12 months

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 moderate to severe rheumatoid arthritis initiated on treatment with RoActemra/Actemra in combination with methotrexate

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)

You may not qualify if:

  • History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
  • Active, severe infection or history of recurrent clinically significant infection
  • Pregnancy
  • Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
  • Methotrexate intolerance

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, 9023, 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

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

June 28, 2011

First Posted

June 29, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

HU(20)