None listed
Conditions
Brief summary
Psoriatic arthritis (PsA) is a type of inflammatory arthritis that presents with erosive joint disease (which may lead to joint deformity) and a psoriasis rash on the skin. It is considered an auto-immune disease which means that the person's own immune system is responsible for the disease. Within the blood of patients with PsA, there are lots of proteins called Inter-Leukin-17 (IL-17). These are inflammatory messengers, which cause inflammation. These messengers tell the body that the inflammation process should occur. RO5130074 is an anti-body against IL-17 messangers. It is also a protein, and it binds to IL-17 making it inactive, and therefore stopping the inflammation process. This study will aim to look at the safety and how well RO5130074 is tolerated in the body of patients with PsA. Nonclinical data supporting IV administration of RO5310074 to humans were obtained from one single-dose and two repeated-dose studies in cynomolgus monkeys. RO5310074 was previously tested clinically in the Roche study PP22712 (a single assending dose study), to assess the safety and tollerability in healthy patients. All doses were well tolerated, with no drug-related, clinically significant adverse events (AEs) reported.
Interventions
The drug being studied is called RO5310074, and it is administered intravenously (into a vein in the arm).
It is being studied for it's effectiveness in the treatment of psoriatic arthritis.
a) There are 3 dose groups (0.5 mg/Kg, 1.4 mg/Kg and 4.5 mg/Kg).
b) Doses will be administered every 2 weeks.
c) Each group will receive 6 infusions. (There will be a total of 12 weeks where study drug is administered; however, the total study duration is 29 weeks. The rest of the time will consist of the in
The drug being studied is called RO5310074, and it is administered intravenously (into a vein in the arm). It is being studied for it's effectiveness in the treatment of psoriatic arthritis. a) There are 3 dose groups (0.5 mg/Kg, 1.4 mg/Kg and 4.5 mg/Kg). b) Doses will be administered every 2 weeks. c) Each group will receive 6 infusions. (There will be a total of 12 weeks where study drug is administered; however, the total study duration is 29 weeks. The rest of the time will consist of the initial screening and post drug out-patient follow up visits). There will be a minimum of 2 weeks between each infusion to allow for safety and tollerability assessments. Only 1 dose group will be dosed at a time, once safety and tollerability are assessed and it is deemed safe to continue, the next dose group will be dosed. d) The total amount of drug (dependant on patient weight) will be diluted in a 500mL bag of 0.9% saline (Sodium Chloride-NaCl) and infused over 1 hour.
Sponsors
Roche Products Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed