A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488

NCT01715831 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ML28091
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 9

Brief Summary

This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with RA. Participants who have completed the MA21488 (NCT00810199) core study and the ML21530 (NCT00754572) study and who could benefit from the study drug, according to the opinion of the investigator, will receive 8 milligrams per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The anticipated time on study treatment is 104 weeks.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)

  An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; significant medical event, according to the investigator discretion (e.g., may represent a risk to the participant or may require medical/surgical intervention to prevent one of the outcomes mentioned above).

  From Baseline up to approximately 2 years

• Number of Participants With AEs Leading to Dose Modification or Study Discontinuation

  From Baseline up to approximately 2 years

• Number of Participants With AEs of Special Interest

  Adverse events of special interest included following events: Infections (including opportunistic infections); myocardial infarction / acute coronary syndrome; gastrointestinal (GI) perforations and related events; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; hemorrhagic events; and hepatic events. Overall number of participants who experienced any of these AEs of special interest was reported.

  From Baseline up to approximately 2 years

Secondary Outcomes (10)

• Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and follow-up (FU) Visit 1 (Week 108), FU Visit 2 (Week 116)

• Tender Joint Count (TJC)

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)

• Swollen Joint Count (SJC)

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)

• Global Evaluation of Disease Activity by the Participant Using VAS Score

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)

• Global Evaluation of Disease Activity by the Physician Using VAS Score

  Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)

Study Arms (1)

Tocilizumab

EXPERIMENTAL

Participants will receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant will be of 800 mg of tocilizumab. Participants may also receive disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.

Drug: DMARDs; Drug: Tocilizumab

Interventions

DMARDs DRUG

DMARDs may be added to the tocilizumab treatment in any visit, at the discretion of the investigator, according to the local prescription information and participant's tolerance. Study protocol does not specify any particular DMARD.

Tocilizumab

Tocilizumab DRUG

Tocilizumab will be administered at 8 mg/kg IV dose every 4 weeks for 104 weeks

Also known as: RoActemra; Actemra

Tocilizumab

Eligibility Criteria

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

You may qualify if:

• Participants who have completed their last visit in the core studies ML21530 and MA21488 and that might benefit from treatment using the study drug according to the investigator's evaluation
• Absence of an AE or current or recent laboratory finding that would prevent the use of the 8 mg/kg dose of the tocilizumab
• Receiving outpatient treatment
• For women who are not postmenopausal and are not surgically sterile: agreement to use at least one adequate method of contraception

You may not qualify if:

• Participants who have prematurely discontinued the core studies ML21530 and MA21488 for any reason
• MA21488 study participants who remained untreated with tocilizumab after it's discontinuation according to the treatment-free remission criteria of MA21488 study
• Immunization with a live/attenuated vaccine since the last administration of the study drug in the core studies ML21530 and ML21488
• Diagnosis after the last visit of the study ML21530 or after the last visit of the study MA21488 of a rheumatic autoimmune disease other than RA, including systemic erythematous lupus (SEL), mixed connective tissue disease (MCTD), scleroderma and polymyositis, or a significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjogren's Syndrome and/or nodulosis with RA are allowed
• Diagnosis after the last visit of the core study ML21530 or of the study MA21488 of an inflammatory joint disease other than RA
• Abnormal laboratory parameters at the baseline
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Evidences of a concomitant, serious and uncontrolled illness
• Known active condition or a history of recurrent infections by bacteria, viruses, fungi, mycobacteria or other agents
• Evidence of an active malignant disease, malignancies diagnosed in the last 10 years or breast cancer diagnosed in the last 20 years
• Uncontrolled disease status, such as asthma or inflammatory bowel disease in which acute crises are usually treated with oral or parenteral corticosteroids
• Current hepatic disease, as determined by the investigator
• Active tuberculosis (TB) requiring treatment in the previous three years. Participants should be screened for latent TB according to local practice guidelines and should not be admitted into the study if latent TB is detected. Participants must not present any evidence of active TB infection at the enrollment. Participants treated for tuberculosis without recurrence in three years are allowed

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

Hospital Universitario Cassiano Antonio Moraes - UFES; Reumatologia

Vitória, Espírito Santo, 29043-910, Brazil

Location

Santa Casa de Misericordia de Salvador; Reumatologia

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Centro Mineiro de Pesquisa - CMIP

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

Location

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, 13083-888, Brazil

Location

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

São Paulo, São Paulo, 04026-000, Brazil

Location

Hospital Abreu Sodre - AACD;Reumatologia

São Paulo, São Paulo, 04027-000, Brazil

Location

Hospital Estadual do Servidor Publico; Reumatologia

São Paulo, São Paulo, 04039-004, Brazil

Location

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, 04266-010, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Antirheumatic Agents; tocilizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: January 15, 2013
• Primary Completion: June 6, 2016
• Study Completion: June 6, 2016
• Last Updated: June 12, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-05

Locations

BR (9)