NCT01670045

Brief Summary

This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed 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
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

9 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

March 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 10, 2016

Completed
Last Updated

October 24, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

August 17, 2012

Results QC Date

April 6, 2016

Last Update Submit

September 14, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation

    Month 6

Secondary Outcomes (12)

  • Percentage of Participants With RA Diagnosis

    Baseline up to Day 5

  • Percentage of Participants With Different Body Mass Index (BMI)

    Baseline up to Day 5

  • Percentage of Participants With Rheumatoid Factor Status

    Baseline up to Day 5

  • Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status

    Baseline up to Day 5

  • Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline

    Baseline, Month 1, 2, 3, 4, 5, 6

  • +7 more secondary outcomes

Study Arms (1)

Rheumatoid Arthritis Participants

Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study will receive tocilizumab in accordance with the licensed label recommendations, and will be observed for 6 months. The study is designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication is required.

Drug: Tocilizumab

Interventions

TocilizumabDRUG

Tocilizumab in accordance with the licensed label recommendation.

Rheumatoid Arthritis Participants

Eligibility Criteria

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

Patients with rheumatoid arthritis initiating treatment with RoActemra/Actemra

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or need of RoActemra/Actemra monotherapy); this can include patients who have received RoActemra/Actemra treatment within 8 weeks 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
  • Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Balikpapan, 76121, Indonesia

Location

Unknown Facility

Bandung, 40161, Indonesia

Location

Unknown Facility

Central Jakarta, 10430, Indonesia

Location

Unknown Facility

Central Java, Indonesia

Location

Unknown Facility

Denpasar, Indonesia

Location

Unknown Facility

Jakarta, Indonesia

Location

Unknown Facility

Malang, 65111, Indonesia

Location

Unknown Facility

Manado, 95115, Indonesia

Location

Unknown Facility

Medan, 20157, Indonesia

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-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 17, 2012

First Posted

August 21, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 24, 2016

Results First Posted

May 10, 2016

Record last verified: 2016-09

Locations

ID(9)