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.

NCT02011334 | Completed Phase 3

• 1 other identifier: ML28700
• Study Type: interventional
• Target: 285
• Locations: 6 countries
• Sites: 25

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (12)

• Safety: Incidence of adverse events (AE)

  60 weeks

• Efficacy: Change in DAS28-ESR

  From baseline to Week 52

• Efficacy: ACR/EULAR responses

  52 weeks

• Efficacy: Change in disease activity (CDAI/SDAI)

  From baseline to Week 52

• Efficacy: Change in joint swelling/tenderness (SJC/TJC)

  From baseline to Week 52

Study Arms (1)

RoActemra/Actemra

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

162 mg will be administered once weekly by subcutaneous injection.

RoActemra/Actemra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (25)

Unknown Facility

Buenos Aires, C1015ABO, Argentina

Location

Unknown Facility

Buenos Aires, C1426AAL, Argentina

Location

Unknown Facility

Buenos Aires, C1428DQG, Argentina

Location

Unknown Facility

C. A. B. A., C1055AAF, Argentina

Location

Unknown Facility

Córdoba, 5000, Argentina

Location

Unknown Facility

Rosario, S2000PBJ, Argentina

Location

Unknown Facility

Goiânia, Goiás, 74110010, Brazil

Location

Unknown Facility

Cuiabá, Mato Grosso, 78025-000, Brazil

Location

Unknown Facility

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 20950-000, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 01244-030, Brazil

Location

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São Paulo, São Paulo, 04026-000, Brazil

Location

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São Paulo, São Paulo, 05437-010, Brazil

Location

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Bogota D.C., Colombia

Location

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Bucaramanga, Colombia

Location

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Medellín, Colombia

Location

Unknown Facility

Santo Domingo, 10208, Dominican Republic

Location

Unknown Facility

Mexico City, 06726, Mexico

Location

Unknown Facility

Mérida, 97000, Mexico

Location

Unknown Facility

Morelia, 58070, Mexico

Location

Unknown Facility

Maracaibo, 4001, Venezuela

Location

Unknown Facility

Punto Fijo, 4102, Venezuela

Location

Related Publications (3)

• Mysler E, Cardiel MH, Xavier RM, Lopez A, Ramos-Esquivel A. Subcutaneous Tocilizumab in Monotherapy or in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs in Latin American Patients With Moderate to Severe Active Rheumatoid Arthritis: A Multicenter, Phase IIIb Study. J Clin Rheumatol. 2020 Oct;26(7S Suppl 2):S180-S186. doi: 10.1097/RHU.0000000000001361.

  PMID: 32251060 DERIVED

• Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

  PMID: 30649524 DERIVED

• Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.

  PMID: 29244149 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 13, 2013
• Study Start: July 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CO (3); AR (6); BR (10); DO (1); VE (2); ME (3)