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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01669902
First received: August 13, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumato id arthritis unable to use methotrexate. Eligible patients initiated on RoActemr

a/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:


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 ]

Enrollment: 107
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669902

Locations
Denmark
Esbjerg, Denmark, 6700
Holbæk, Denmark, 4300
Kolding, Denmark, 6000
Køge, Denmark, 4600
Svendborg, Denmark, 5700
Vejle, Denmark, 7100
Norway
Bergen, Norway, 5053
Gjettum, Norway, 1346
Moss, Norway, 1535
Skien, Norway, 3722
Trondheim, Norway, 7030
Sweden
Falun, Sweden, SE-791 82
Farsta, Sweden, 541 85
Goteborg, Sweden, 413 45
Helsingborg, Sweden, 251 87
Hudiksvall, Sweden, 824 81
Jönköping, Sweden, 551 85
Karlskrona, Sweden, 37185
Karlstad, Sweden, 65185
Kristianstad, Sweden, 29185
Malmo, Sweden, 205 02
Simrishamn, Sweden, 272 81
Skoevde, Sweden, 54185
Trelleborg, Sweden, 231 85
Uppsala, Sweden, 75185
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: August 4, 2014
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 September 11, 2014