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.

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT02011334
• Date of registration: 04/12/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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.
• Scientific 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
• Date of first enrolment: July 2014
• Target sample size: 285
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02011334
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Colombia, Dominican Republic, Ecuador, Mexico, Uruguay, Venezuela

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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 ( 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: tocilizumab [RoActemra/Actemra]

Primary Outcome(s)

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

Secondary Outcome(s)

Efficacy: Change in joint swelling/tenderness (SJC/TJC) [Time Frame: From baseline to Week 52]

Efficacy: Proportion of patients who maintain DAS28 Remission/LDA [Time Frame: From Week 24 to Week 52]

Safety: Assessment of immunogenicity [Time Frame: 60 weeks]

Efficacy: Change in DAS28-ESR [Time Frame: From baseline to Week 52]

Patient-reported outcomes [Time Frame: 60 weeks]

Efficacy: Change in disease activity (CDAI/SDAI) [Time Frame: From baseline to Week 52]

Safety: Rates of AE leading to dose modification or study withdrawal [Time Frame: 52 weeks]

Efficacy: DAS28-ESR Remission Rate [Time Frame: 52 weeks]

Safety: Incidence of adverse events (AE) [Time Frame: 60 weeks]

Safety: Incidence of clinically significant laboratory abnormalities following treatment [Time Frame: 52 weeks]

Efficacy: ACR/EULAR responses [Time Frame: 52 weeks]

Safety: Assessment of physical examination and vital signs [Time Frame: 52 weeks]

Secondary ID(s)

ML28700

Source(s) of Monetary Support

Please refer to primary and secondary sponsors