An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01337388
First received: April 15, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will assess the efficacy and safety of RoActemra/Actemr a (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis Data from patients treated in routine clinical practice with intravenous RoAct emra/Actemra will be collected for 12 months each.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Efficacy of RoActemra in Smoking vs Non-smoking Patients With Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in disease activity score (DAS 28) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of patients achieving remission (DAS <2.6) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Change in blood lipids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: August 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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

Rheumatoid arthritis patients on treatment with RoActemra/Actemra

Criteria

Inclusion Criteria:

  • Adult patients, > 18 years of age
  • Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria
  • Treatment with RoActemra/Actemra

Exclusion Criteria:

  • Participation in interventional clinical studies
  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: NCT01337388

Locations
Norway
Bergen, Norway, 5053
Drammen, Norway, 3004
Gjettum, Norway, 1346
Kristiansand, Norway, 4604
Levanger, Norway, 7600
Lillehammer, Norway, 2609
Skien, Norway, 3722
Trondheim, Norway, 7030
Ålesund, Norway, 6017
Sweden
Eskilstuna, Sweden, 631 88
Falun, Sweden, 79182
Farsta, Sweden, 541 85
Göteborg, Sweden, 413 45
Kalmar, Sweden, 39185
Karlstad, Sweden, 65185
Kristianstad, Sweden, 29185
Linkoeping, Sweden, 58185
Lulea, Sweden, 97180
Malmo, Sweden, 205 02
Oerebro, Sweden, 70185
Oskarstroem, Sweden, 31392
Simrishamn, Sweden, 272 81
Skoevde, Sweden, 54185
Stockholm, Sweden, 171 76
Stockholm, Sweden, 205 02
Uddevalla, Sweden, 45180
Uppsala, Sweden, 75185
Västerås, Sweden, 72189
Östersund, Sweden, 831 02
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: NCT01337388     History of Changes
Other Study ID Numbers: ML25492
Study First Received: April 15, 2011
Last Updated: August 4, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics

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 22, 2014