A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis RA . - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-003694-25-IT
• Date of registration: 27/01/2006
• Prospective Registration: No
• Primary sponsor: ROCHE
• Public title: A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis RA . - ND
• Scientific title: A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis RA . - ND
• Date of first enrolment: 12/01/2006
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003694-25
• 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

Countries of recruitment

Czech Republic, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Able and willing to give written informed consent and to comply with the study protocol 2. Active RA as diagnosed by the 1987 American College of Rheumatology ACR; formerly American Rheumatism Association criteria Appendix 2 3. Age 18 years 4. Receiving treatment for RA on an outpatient basis 5. Swollen joint count 6 66 joint count and tender joint count TJC 8 68 joint count at screening and baseline 6. At screening, either high sensitivity C-reactive protein hs-CRP 0.6 mg/dL 6 mg/L or erythrocyte sedimentation rate ESR 28 mm/h or morning stiffness 45 minutes 7. Females of child-bearing potential and nonsterilized males with female partners of child-bearing potential only if willing to use a reliable means of contraception e.g., physical barrier, contraceptive pill, patch, or IUD during the study and for 4 weeks following the last dose of study drug. 8. If female and of childbearing potential, must have a negative pregnancy test within 3 weeks prior to randomization and at baseline prior to administration of study drug on Day 1 .
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Major surgery including joint surgery within 8 weeks prior to screening or planned surgery within 3 months after randomization 2. Rheumatic autoimmune disease other than RA including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to RA e.g., vasculitis, pulmonary fibrosis, Felty s syndrome ; Sj gren s Syndrome with RA is allowed 3. Bed-ridden or confined to a wheelchair 4. Prior history of or current inflammatory joint disease other than RA e.g., tophaceous gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease


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

Health Condition(s) or Problem(s) studied

rheumatoid arthritis
MedDRA version: 6.1 Level: PT Classification code 10039073

Intervention(s)

Product Name: P38 Map Kinase Inhibitor
Pharmaceutical Form: Film-coated tablet
CAS Number: 449811-01-2
Current Sponsor code: RO 4402257
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: P38 Map Kinase Inhibitor
Pharmaceutical Form: Film-coated tablet
CAS Number: 449811-01-2
Current Sponsor code: RO 4402257
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: P38 Map Kinase Inhibitor
Pharmaceutical Form: Film-coated tablet
CAS Number: 449811-01-2
Current Sponsor code: RO 4402257
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
CAS Number: 449811-01-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary efficacy parameter is the proportion of patients with an ACR20 response at Week 12. According to the American College of Rheumatology response criteria, achievement of an ACR20 response requires at least a 20 improvement, compared to baseline, in both tender and swollen joint counts, as well as in 3 out of the 5 following parameters physician s global assessment of disease activity, patient s global assessment of disease activity, patient s assessment of pain, HAQ, and an acute phase reactant, either hs-CRP or ESR.

Main Objective: To assess the efficacy of RO4402257 as monotherapy in adult patients with active RA.

Secondary Objective: 1. To assess the safety profile of RO4402257 as monotherapy in RA patients. 2. To assess the efficacy and safety of several dose levels of RO4402257. 3. To collect sparse pharmacokinetic PK sampling data that can be combined with PK sampling data from other RO4402257 studies in order to investigate the PK profile of RO4402257 in the target RA patient population by a population analysis approach.

Secondary ID(s)

PA 18604

2005-003694-25-ES