A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00316771

Enrollment

374

Registered

2006-04-21

Start date

2005-11-30

Completion date

2008-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGP38 Inhibitor (4) 150mg

150mg po qd

DRUGP38 Inhibitor (4) 25mg

25mg po bid

DRUGP38 Inhibitor (4) 300mg

300mg po qd

DRUGP38 Inhibitor (4) 50mg

50mg po qd

DRUGP38 Inhibitor (4) 75mg

75mg po bid

DRUGPlacebo

po bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adult patients \>=18 years of age; * active rheumatoid arthritis; * current inadequate clinical response to methotrexate.

Exclusion criteria

* receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.

Design outcomes

Primary

Measure	Time frame
Percentage of patients with ACR 20 response	Week 12

Secondary

Measure	Time frame
Percentage of patients with ACR 50/70 response	Week 12
Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab parameters.	Throughout study

Countries

Australia, Brazil, Canada, Estonia, Germany, Greece, Ireland, Mexico, New Zealand, Poland, South Africa, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026