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An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01669902
First received: August 13, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients on RoActemra/Actemra treatment at 6 months after treatment initiation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of dose modifications/interruptions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Patient recorded outcomes: Health Assessment Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with active moderate to severe rheumatoid arthritis unable to use methotrexate

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669902

Contacts
Contact: Reference Study ID Number: ML28247 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Denmark
Recruiting
Esbjerg, Denmark, 6700
Recruiting
Holbæk, Denmark, 4300
Recruiting
Kolding, Denmark, 6000
Recruiting
Køge, Denmark, 4600
Recruiting
Svendborg, Denmark, 5700
Norway
Recruiting
Bergen, Norway, 5053
Recruiting
Gjettum, Norway, 1346
Not yet recruiting
Moss, Norway, 1535
Recruiting
Skien, Norway, 3722
Recruiting
Trondheim, Norway, 7030
Sweden
Recruiting
Falun, Sweden, SE-791 82
Recruiting
Farsta, Sweden, 541 85
Recruiting
Goteborg, Sweden, 41345
Recruiting
Helsingborg, Sweden, 251 87
Recruiting
Hudiksvall, Sweden, 824 81
Recruiting
Jönköping, Sweden, 551 85
Recruiting
Karlskrona, Sweden, 37185
Recruiting
Karlstad, Sweden, 65185
Recruiting
Kristianstad, Sweden, 29185
Recruiting
Malmo, Sweden, 205 02
Recruiting
Simrishamn, Sweden, 272 81
Recruiting
Skoevde, Sweden, 54185
Recruiting
Trelleborg, Sweden, 231 85
Recruiting
Uppsala, Sweden, 751 85
Recruiting
Västerås, Sweden, 72189
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01669902     History of Changes
Other Study ID Numbers: ML28247
Study First Received: August 13, 2012
Last Updated: June 3, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013