A comparison of tocilizumab and adalimumab in patients with rheumatoid arthritis looking at improvement in joint pain, joint swelling and general disease activity.

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2009-015845-21-ES
• Date of registration: 12/01/2012
• Prospective Registration: No
• Primary sponsor: F. Hoffmann-La Roche Ltd.
• Public title: A comparison of tocilizumab and adalimumab in patients with rheumatoid arthritis looking at improvement in joint pain, joint swelling and general disease activity.
• Scientific title: A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis.
• Date of first enrolment: 12/05/2010
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015845-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Australia, Belgium, Brazil, Czech Republic, Finland, Germany, Greece, Mexico, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- pacientes adultos, >/=18 años.

- artritis reumatoide de >6 meses de duración.

- intolerancia al metotrexato o que el tratamiento continuado se considere inadecuado.

- se debe suspender el tratamiento con todos los FAMEs antes de recibir la medicación del estudio.

- peso
4. Pacientes tratados previa o actualmente con MTX y que presenten intolerancia a este fármaco o para los que el tratamiento continuado con MTX se considere inadecuado por, al menos, uno de los motivos siguientes:
a) problemas de seguridad significativos,
b) respuesta inadecuada o,
c) cualquier otro motivo por el que el investigador considere que el tratamiento continuado con MTX resulta inadecuado.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 251
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion criteria:
- cirugía mayor (incluyendo cirugía articular) en las 12 semanas previas a la evaluación basal o que esté previsto una intervención mayor en los 6 meses siguientes a dicha visita.

- antecedentes o historia actual de enfermedad articular inflamatoria distinta a la AR.

- tratamiento con un agente biológico en cualquier momento antes de la visita basal.

- corticoesteroides intraarticulares o parenterales
- infecciones activas en la actualidad o antecedentes de infecciones recurrentes de tipo bacteriano, viral, micótico o micobacteriano.

- antecedentes de reacciones alérgicas o anafilácticas severas a anticuerpos monoclonales
humanizados o murinos o al látex (debido a que la tapa de la aguja de Humira está
hecha de látex).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
Current Sponsor code: Ro 487-7533/F01
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
Current Sponsor code: RO 551-6922
Other descriptive name: ADALIMUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: Comparar la variación producida en el DAS28 desde la evaluación basal hasta la semana 24 en pacientes tratados con Tocilizumab (TCZ) frente a los que reciben Adalimumab (ADA).

Primary end point(s): The primary endpoint is the change in DAS28 at Week 24.

Timepoint(s) of evaluation of this end point: Week 24

Secondary Objective: - Evaluar los parámetros de eficacia usando los criterios ACR, EULAR y los resultados de las evaluaciones de salud del paciente.
- Comparar los acontecimientos adversos
- Comparar los cambios de laboratorio

Secondary Outcome(s)

Secondary end point(s): 1) Proportion of patients with an American College of Rheumatolgy
(ACR) reponse at Week 24
2) Proportion of patients with a European League Against Rheumatism
(EULAR) response at Week 24
3) Incidence of adverse events (AEs)
4) Laboratory parameters (blood samples)
5) Quality of Life (QoL) as assessed through the Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue questionnaire

Timepoint(s) of evaluation of this end point: 1) 24 weeks
2) 24 weeks
3) 24 weeks of treatment and 8 weeks of follow-up
4) Assessments every 4 weeks
5) Weeks 4, 8, 12, 16, 20 and 24

Secondary ID(s)

WA19924

2009-015845-21-GB

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date: 06/05/2010
Contact:

Results

• Results available: Yes
• Date Posted: 22/05/2015
• Date Completed: 31/01/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-015845-21/results