Clinical trial NCT01715831: A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488
Official title: A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* History of alcohol, drugs or chemical abuse since the inclusion in the core studies ML21530 and MA21488

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)
timeFrame: From Baseline up to approximately 2 years
measure: Number of Participants With AEs Leading to Dose Modification or Study Discontinuation
timeFrame: From Baseline up to approximately 2 years
measure: Number of Participants With AEs of Special Interest
timeFrame: From Baseline up to approximately 2 years
Secondary outcomes:
measure: Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and follow-up (FU) Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: Tender Joint Count (TJC)
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: Swollen Joint Count (SJC)
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: Global Evaluation of Disease Activity by the Participant Using VAS Score
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: Global Evaluation of Disease Activity by the Physician Using VAS Score
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: Participant's Pain Assessment Using VAS Score
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: Health Assessment Questionnaire (HAQ) Pain VAS Score
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: C-Reactive Protein (CRP) Level
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
measure: ESR Level
timeFrame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Santa Casa de Misericordia de Salvador; Reumatologia
state: BA
city: Vitoria
country: Brazil
facility: Hospital Universitario Cassiano Antonio Moraes - UFES; Reumatologia
state: ES
city: Juiz de Fora
country: Brazil
facility: Centro Mineiro de Pesquisa - CMIP
state: MG
city: Campinas
country: Brazil
facility: Hospital das Clinicas - UNICAMP
state: SP
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP; Reumatologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Abreu Sodre - AACD;Reumatologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Estadual do Servidor Publico; Reumatologia
state: SP
city: Sao Paulo
country: Brazil
facility: Centro Paulista de Investigacao Clinica - CEPIC
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: