A randomized, blinded study, using multiple increasing doses of RO5310074, studying the effects of RO5310074 in patients with psoriatic arthritis

Phase 1

• Conditions: Psoriatic arthritis; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12610000694011
• Lead Sponsor: Roche Products Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Male and female subjects, 18 to 75 years of age, inclusive, with psoriatic arthritis diagnosed by the Moll and Wright criteria with peripheral joint involvement of at least 6 months duration; this includes subjects with
psoriatic arthritis subtypes such as arthritis affecting Distal Inter-Phalangeal (DIP) joints, arthritis
mutilans, asymmetric peripheral arthritis, polyarticular arthritis with absence of rheumatoid nodes, and spondylitis with peripheral arthritis
2. Either a high sensitivity C-reactive protein (hsCRP) greater than or equal to 0.7 mg/dL or a
erythrocyte sedimentation rate (ESR) greater than or equal to 20 mm/hr
3. If currently taking Methotrexate (MTX), patients must be willing to receive oral folic acid at a stable dose of at least 5 mg/week
4. A body mass index (BMI) between 18 and 35 kg/m2, inclusive
5. A normal screening ECG
6. Women of child bearing age must be willing to use a reliable method of birth control.

Exclusion Criteria

1. Prior treatment of any biologic Disease Modifying Anti-Rheumatic Drugs (DMARDS)
2. Topical therapy for treatment of psoriasis within 14 days prior to administration of study drug.
3. Abnormal laboratory tests.
4. Any prior immune diseases.
5. History of any other inflammatory joint disease (other than psoriatic arthritis).
6. History of any skin conditions that would interfere with the evaluation of psoriasis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified