NCT01669902

Brief Summary

This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
3 countries

26 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

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 23, 2015

Completed
Last Updated

November 23, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

August 13, 2012

Results QC Date

October 21, 2015

Last Update Submit

October 21, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants on Tocilizumab Treatment at Month 6

    Month 6

Secondary Outcomes (23)

  • Percentage of Participants With Dose Modifications of Tocilizumab

    Baseline to Month 6

  • Swollen Joint Count (SJC)

    Baseline, Month 3, Month 6

  • Tender Joint Count (TJC)

    Baseline, Month 3, Month 6

  • Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])

    Baseline, Month 3, Month 6

  • Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)

    Month 3 and Month 6

  • +18 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 active moderate to severe rheumatoid arthritis unable to use methotrexate

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
  • Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed

You may not qualify if:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Esbjerg, 6700, Denmark

Location

Unknown Facility

Holbæk, 4300, Denmark

Location

Unknown Facility

Kolding, 6000, Denmark

Location

Unknown Facility

Køge, 4600, Denmark

Location

Unknown Facility

Svendborg, 5700, Denmark

Location

Unknown Facility

Vejle, 7100, Denmark

Location

Unknown Facility

Bergen, 5053, Norway

Location

Unknown Facility

Gjettum, 1346, Norway

Location

Unknown Facility

Moss, 1535, Norway

Location

Unknown Facility

Skien, 3722, Norway

Location

Unknown Facility

Trondheim, 7030, Norway

Location

Unknown Facility

Falun, SE-791 82, Sweden

Location

Unknown Facility

Farsta, 541 85, Sweden

Location

Unknown Facility

Gothenburg, 413 45, Sweden

Location

Unknown Facility

Helsingborg, 251 87, Sweden

Location

Unknown Facility

Hudiksvall, 824 81, Sweden

Location

Unknown Facility

Jönköping, 551 85, Sweden

Location

Unknown Facility

Karlskrona, 37185, Sweden

Location

Unknown Facility

Karlstad, 65185, Sweden

Location

Unknown Facility

Kristianstad, 29185, Sweden

Location

Unknown Facility

Malmo, 205 02, Sweden

Location

Unknown Facility

Simrishamn, 272 81, Sweden

Location

Unknown Facility

Skövde, 54185, Sweden

Location

Unknown Facility

Trelleborg, 231 85, Sweden

Location

Unknown Facility

Uppsala, 75185, Sweden

Location

Unknown Facility

Västerås, 72189, Sweden

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 13, 2012

First Posted

August 21, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 23, 2015

Results First Posted

November 23, 2015

Record last verified: 2015-10

Locations

DK(6)SE(15)NO(5)