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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337388
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 197 participants
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.
Study Start Date : August 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Change in disease activity score (DAS 28) [ Time Frame: 12 months ]
  2. Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 36 months ]
  2. Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire [ Time Frame: 12 months ]
  3. Rate of patients achieving remission (DAS <2.6) [ Time Frame: 36 months ]
  4. Change in blood lipids [ Time Frame: 12 months ]
  5. Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate [ Time Frame: 36 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Rheumatoid arthritis patients on treatment with RoActemra/Actemra

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01337388

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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
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
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01337388    
Other Study ID Numbers: ML25492
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases