Clinical trial NCT01399697: A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Official title: A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis (DAS28 \>/= 3.2) at baseline
* Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
* Body weight \< 150 kg
* Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day

Exclusion Criteria:

* Pregnant or nursing women
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than RA
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
* Prior history of or current inflammatory joint disease other than RA
* Treatment with a biologic agent at any time prior to baseline
* Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Known active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for HIV infection

Primary outcomes:
measure: Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28
timeFrame: Baseline, Week 16, and Week 28
Secondary outcomes:
measure: Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28
timeFrame: Week 28
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28
timeFrame: Week 28
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28
timeFrame: 28 weeks
measure: Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28
timeFrame: Week 16 and Week 28
measure: Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health
timeFrame: Week 16 and Week 28
measure: Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health
timeFrame: Week 16 and Week 28
measure: Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant
timeFrame: Week 16 and Week 28
measure: Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator
timeFrame: Week 16 and Week 28
Other outcomes:
Locations:
city: Orihuela
country: Spain
state: Alicante
city: Torrevieja
country: Spain
state: Alicante
city: Villajoyosa
country: Spain
state: Alicante
city: Merida
country: Spain
state: Badajoz
city: Badalona
country: Spain
state: Barcelona
city: Granollers
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: Cádiz
country: Spain
state: Cadiz
city: Torrelavega
country: Spain
state: Cantabria
city: Villarreal
country: Spain
state: Castellon
city: Menorca
country: Spain
state: Islas Baleares
city: A Coruna
country: Spain
state: La Coruña
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Las Palmas De Gran Canaria
country: Spain
state: Las Palmas
city: Alcala de Henares
country: Spain
state: Madrid
city: Fuenlabrada
country: Spain
state: Madrid
city: Valdemoro
country: Spain
state: Madrid
city: Cartagena
country: Spain
state: Murcia
city: El Palmar
country: Spain
state: Murcia
city: Vigo
country: Spain
state: Pontevedra
city: Manises
country: Spain
state: Valencia
city: Valenica
country: Spain
state: Valencia
city: Barakaldo
country: Spain
state: Vizcaya
city: Bilbao
country: Spain
state: Vizcaya
city: Galdakao
country: Spain
state: Vizcaya
city: Albacete
country: Spain
city: Badajoz
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Caceres
country: Spain
city: Cordoba
country: Spain
city: Granada
country: Spain
city: Granada
country: Spain
city: Guadalajara
country: Spain
city: Leon
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Tenerife
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: