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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00316771




Registration number
NCT00316771
Ethics application status
Date submitted
20/04/2006
Date registered
21/04/2006
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Scientific title
A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.
Secondary ID [1] 0 0
PA18439
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - P38 Inhibitor (4) 150mg
Treatment: Drugs - P38 Inhibitor (4) 25mg
Treatment: Drugs - P38 Inhibitor (4) 300mg
Treatment: Drugs - P38 Inhibitor (4) 50mg
Treatment: Drugs - P38 Inhibitor (4) 75mg
Treatment: Drugs - Placebo

Experimental: P38 Inhibitor (4) 150mg -

Experimental: P38 Inhibitor (4) 25mg -

Experimental: P38 Inhibitor (4) 300mg -

Experimental: P38 Inhibitor (4) 50mg -

Experimental: P38 Inhibitor (4) 75mg -

Placebo Comparator: Placebo -


Treatment: Drugs: P38 Inhibitor (4) 150mg
150mg po qd

Treatment: Drugs: P38 Inhibitor (4) 25mg
25mg po bid

Treatment: Drugs: P38 Inhibitor (4) 300mg
300mg po qd

Treatment: Drugs: P38 Inhibitor (4) 50mg
50mg po qd

Treatment: Drugs: P38 Inhibitor (4) 75mg
75mg po bid

Treatment: Drugs: Placebo
po bid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with ACR 20 response
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of patients with ACR 50/70 response
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.
Timepoint [2] 0 0
Throughout study

Eligibility
Key inclusion criteria
- adult patients >=18 years of age;

- active rheumatoid arthritis;

- current inadequate clinical response to methotrexate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- receiving any other disease-modifying anti-rheumatic drug, with the exception of
hydroxychloroquine or chloroquine.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
374
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Caboolture
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Kippa Ring
Recruitment postcode(s) [1] 0 0
4510 - Caboolture
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Elblag
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor
(4) in patients with RA currently having an inadequate clinical response to methotrexate.
Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75
bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time
on study treatment is <3 months, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00316771
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00316771