Skip to main content
OpenTrials
Completed

NCT Number: NCT02011334

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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tocilizumab [RoActemra/Actemra]

Drug

162 mg will be administered once weekly by subcutaneous injection.

Primary outcomes

  1. Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.