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

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ClinicalTrials.gov Identifier: NCT01564901
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.
Study Start Date : January 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort



Primary Outcome Measures :
  1. Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day [ Time Frame: Week 36 ]

Secondary Outcome Measures :
  1. Change from baseline in glucocorticoid dose [ Time Frame: Week 36 ]
  2. Change from baseline in corticosteroid dose [ Time Frame: Week 36 ]
  3. Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose [ Time Frame: Week 36 ]
  4. Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids [ Time Frame: Week 36 ]
  5. Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use [ Time Frame: Week 36 ]
  6. Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day [ Time Frame: Week 36 ]
  7. Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day [ Time Frame: Week 36 ]
  8. Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction [ Time Frame: Week 36 ]
  9. Percentage change in Disease Activity Score 28 (DAS28) [ Time Frame: Week 36 ]
  10. Percentage change in Simplified Disease Activity Index (SDAI) score [ Time Frame: Week 36 ]
  11. Safety: Incidence of adverse events [ Time Frame: 36 weeks ]


Information from the National Library of Medicine

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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
Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids
Criteria

Inclusion Criteria:

  • Adults patients, over 18 years of age
  • Patients with moderate to severe rheumatoid arthritis (RA)
  • Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion

Exclusion Criteria:

  • Patients previously treated with RoActemra/Actemra
  • Any contraindication to RoActemra/Actemra

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 ClinicalTrials.gov identifier (NCT number): NCT01564901


Locations
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Spain
Vitoria, Alava, Spain, 01009
Elche, Alicante, Spain, 03203
San Sebastian, Guipuzcoa, Spain, 20080
Palma de Mallorca, Islas Baleares, Spain, 07198
Ponferrada, Leon, Spain, 24411
Alzira, Valencia, Spain, 46600
Bilbao, Vizcaya, Spain, 48013
Alicante, Spain, 03700
Huesca, Spain, 22004
Leon, Spain, 24071
Salamanca, Spain, 37007
Valencia, Spain, 46340
Valencia, Spain, 46520
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01564901    
Other Study ID Numbers: ML27904
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases