Clinical trial NCT00754572: A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official title: A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is \<500 individuals.


Eligibility criteria: Inclusion Criteria:

* patients \>=18 years with moderate to severe active RA for at least 6 months;
* swollen joint count \>=6 (66 joint count) and tender joint count \>=8 (68 joint count) at screening;
* inadequate response to stable dose of MTX;
* patients of reproductive potential must be using a reliable means of contraception.

Exclusion Criteria:

* rheumatic autoimmune disease other than RA;
* patients with functional class IV RA;
* diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
* prior treatment failure with anti-tumor necrosis factor agent;
* pregnant or breastfeeding women.

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With ACR20 and ACR70 Response at Week 24
timeFrame: Week 24
measure: Time to Onset of ACR20, ACR50, and ACR70
timeFrame: Baseline and Week 24
measure: Change From Baseline in Hemoglobin at Week 24
timeFrame: Baseline and Week 24
measure: SJC and TJC at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in SJC and TJC at Week 24
timeFrame: Baseline and Week 24
measure: Pain as Assessed by the Participant at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in Pain as Assessed by the Participant at Week 24
timeFrame: Baseline and Week 24
measure: Participant's Global Assessment of Disease Activity at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24
timeFrame: Baseline and Week 24
measure: Physician's Global Assessment of Disease Activity at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24
timeFrame: Baseline and Week 24
measure: HAQ-DI at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in HAQ-DI at Week 24
timeFrame: Baseline and Week 24
measure: Area Under The Curve (AUC) of the ACR(n)
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving ACR20 Response
timeFrame: Week 2
measure: Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24
measure: Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24
timeFrame: Week 24
measure: AUC of DAS28
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24
timeFrame: Week 24
measure: Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24
timeFrame: Week 24
measure: Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Córdoba
country: Argentina
city: San Miguel De Tucuman
country: Argentina
city: San Miguel
country: Argentina
city: Salvador
country: Brazil
state: BA
city: Fortaleza
country: Brazil
state: CE
city: Brasilia
country: Brazil
state: DF
city: Vitoria
country: Brazil
state: ES
city: Belo Horizonte
country: Brazil
state: MG
city: Juiz de Fora
country: Brazil
state: MG
city: Recife
country: Brazil
state: PE
city: Curtiba
country: Brazil
state: PR
city: Rio de Janeiro
country: Brazil
state: RJ
city: Caxias do Sul
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Florianopolis
country: Brazil
state: SC
city: Botucatu
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Sao Jose do Rio Preto
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Concepcion
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Bogota
country: Colombia
city: Bogotá
country: Colombia
city: Bucaramanga
country: Colombia
city: Cali
country: Colombia
city: Chia-Cundinamarca
country: Colombia
city: Medellin
country: Colombia
city: Medellín
country: Colombia
city: Cartago
country: Costa Rica
city: Heredia
country: Costa Rica
city: San Jose
country: Costa Rica
city: San José
country: Costa Rica
city: Cuenca
country: Ecuador
city: Guayaquil
country: Ecuador
city: Quito
country: Ecuador
city: Quito
country: Ecuador
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Miexico City
country: Mexico
city: Queretaro
country: Mexico
city: San Luis Potosi
country: Mexico
city: Arequipa
country: Peru
city: Jesus Maria
country: Peru
city: Lima
country: Peru
city: San Isidro
country: Peru
city: Montevideo
country: Uruguay
city: Barquisimeto
country: Venezuela
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
city: Maracaibo
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: