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A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.

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ClinicalTrials.gov Identifier: NCT02011334
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America with an inadequate response to non-biologic DMARDs.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: tocilizumab [RoActemra/Actemra] Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA
Study Start Date : July 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
162 mg will be administered once weekly by subcutaneous injection.




Primary Outcome Measures :
  1. Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events (AE) [ Time Frame: 60 weeks ]
  2. Efficacy: Change in DAS28-ESR [ Time Frame: From baseline to Week 52 ]
  3. Efficacy: ACR/EULAR responses [ Time Frame: 52 weeks ]
  4. Efficacy: Change in disease activity (CDAI/SDAI) [ Time Frame: From baseline to Week 52 ]
  5. Efficacy: Change in joint swelling/tenderness (SJC/TJC) [ Time Frame: From baseline to Week 52 ]
  6. Safety: Assessment of immunogenicity [ Time Frame: 60 weeks ]
  7. Patient-reported outcomes [ Time Frame: 60 weeks ]
  8. Efficacy: DAS28-ESR Remission Rate [ Time Frame: 52 weeks ]
  9. Efficacy: Proportion of patients who maintain DAS28 Remission/LDA [ Time Frame: From Week 24 to Week 52 ]
  10. Safety: Rates of AE leading to dose modification or study withdrawal [ Time Frame: 52 weeks ]
  11. Safety: Assessment of physical examination and vital signs [ Time Frame: 52 weeks ]
  12. Safety: Incidence of clinically significant laboratory abnormalities following treatment [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >/= 18 years of age.
  • Patients with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
  • Patients with moderate to severe RA (DAS-ESR 28 >/= 3.2).
  • Receiving non-study treatment on an outpatient basis.
  • Oral corticosteroids (</= 10 mg/day prednisone or equivalent), NSAIDs and non-biologic DMARDs are permitted if on a stable dose regimen for >/= 4 weeks prior to Baseline.
  • Inadequate response to previous non-biologic DMARD therapy.
  • Use of effective contraception throughout the study as defined by protocol; female patients of childbearing potential cannot be pregnant.

Exclusion Criteria:

  • Presence of clinically significant medical conditions.
  • History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease that might predispose to perforation.
  • Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections.
  • Any infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
  • Clinically significant findings on lab tests and/or hepatits B or C, or HIV screenings.
  • Active TB requiring treatment within the previous 3 years.
  • Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years.
  • History of alcohol, drug, or chemical abuse within 1 year prior to Screening.
  • Neuropathies or other conditions that might interfere with pain evaluation.
  • Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline.
  • Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted.
  • Functional Class IV as defined by the ACR Classification of Functional Status in-Rheumatoid Arthritis (Appendix 2).
  • Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16.
  • Prior history of or current inflammatory joint disease other than RA.
  • Previous exposure to RoActemra/Actemra (either IV or SC).
  • Prior treatment with a biologic agent.
  • Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.
  • Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
  • Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
  • Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.

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): NCT02011334


Locations
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Argentina
Buenos Aires, Argentina, C1015ABO
Buenos Aires, Argentina, C1426AAL
Buenos Aires, Argentina, C1428DQG
C. A. B. A., Argentina, C1055AAF
Cordoba, Argentina, 5000
Rosario, Argentina, S2000PBJ
Brazil
Goiania, GO, Brazil, 74110010
Juiz de Fora, MG, Brazil, 36036-330
Cuiaba, MT, Brazil, 78025-000
Rio de Janeiro, RJ, Brazil, 20950-000
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90035-170
Porto Alegre, RS, Brazil, 90610-000
Sao Paulo, SP, Brazil, 01244-030
Sao Paulo, SP, Brazil, 04026-000
Sao Paulo, SP, Brazil, 05437-010
Colombia
Bogota D.C., Colombia
Bucaramanga, Colombia
Medellin, Colombia
Dominican Republic
Santo Domingo, Dominican Republic, 10208
Mexico
Merida, Mexico, 97000
Mexico City, Mexico, 06726
Morelia, Mexico, 58070
Venezuela
Maracaibo, Venezuela, 4001
Punto Fijo, Venezuela, 4102
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02011334    
Other Study ID Numbers: ML28700
First Posted: December 13, 2013    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