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Rheumatoid ArthritisPhase 3NCT02011334

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.

A Phase 3 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 25 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
tocilizumab [RoActemra/Actemra]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
285 participants
Where
25 sitesin 6 countries
Study dates
Jul 2014to Oct 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

25 sites in 6 countries.

25 sites in 6 countries

Brazil10 sites

  • Study site

    Cuiabá, Mato Grosso, 78025-000

  • Study site

    Goiânia, Goiás, 74110010

  • Study site

    Juiz de Fora, Minas Gerais, 36036-330

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-170

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20950-000

  • Study site

    São Paulo, São Paulo, 01244-030

  • Study site

    São Paulo, São Paulo, 04026-000

  • Study site

    São Paulo, São Paulo, 05437-010

Other trials in Brazil

Argentina6 sites

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1426AAL

  • Study site

    Buenos Aires, C1428DQG

  • Study site

    C. A. B. A., C1055AAF

  • Study site

    Córdoba, 5000

  • Study site

    Rosario, S2000PBJ

Other trials in Argentina

Colombia3 sites

  • Study site

    Bogota D.C.

  • Study site

    Bucaramanga

  • Study site

    Medellín

Other trials in Colombia

Mexico3 sites

  • Study site

    Mérida, 97000

  • Study site

    Mexico City, 06726

  • Study site

    Morelia, 58070

Other trials in Mexico

Venezuela2 sites

  • Study site

    Maracaibo, 4001

  • Study site

    Punto Fijo, 4102

Other trials in Venezuela

Dominican Republic1 site

  • Study site

    Santo Domingo, 10208

Other trials in Dominican Republic

About this study

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

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.

Being tested
tocilizumab [RoActemra/Actemra]
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tocilizumab [RoActemra/Actemra]Drug

    162 mg will be administered once weekly by subcutaneous injection.

Study groups in NCT02011334
Study groupRoleWhat they receive
RoActemra/ActemraExperimentalNot described
Receives: Drug: tocilizumab [RoActemra/Actemra]

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 weeks

Secondary outcomes (12)

  1. Safety: Incidence of adverse events (AE)

    Measured: 60 weeks

  2. Efficacy: Change in DAS28-ESR

    Measured: From baseline to Week 52

  3. Efficacy: ACR/EULAR responses

    Measured: 52 weeks

  4. Efficacy: Change in disease activity (CDAI/SDAI)

    Measured: From baseline to Week 52

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

    Measured: From baseline to Week 52

  6. Safety: Assessment of immunogenicity

    Measured: 60 weeks

  7. Patient-reported outcomes

    Measured: 60 weeks

  8. Efficacy: DAS28-ESR Remission Rate

    Measured: 52 weeks

  9. Efficacy: Proportion of patients who maintain DAS28 Remission/LDA

    Measured: From Week 24 to Week 52

  10. Safety: Rates of AE leading to dose modification or study withdrawal

    Measured: 52 weeks

  11. Safety: Assessment of physical examination and vital signs

    Measured: 52 weeks

  12. Safety: Incidence of clinically significant laboratory abnormalities following treatment

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2013 (estimated)
  2. Study startJul 2014
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02011334
Sponsor's protocol ID
ML28700
Status last verified
Nov 2016
First submitted
4 Dec 2013
Last updated
2 Nov 2016
Results posted
No

Publications

  • 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.

    PubMed 32251060

  • 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.

    PubMed 30649524

  • 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.

    PubMed 29244149

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 25 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Brazil, Argentina, Colombia, Mexico, Venezuela and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02011334, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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