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RO5310074

Phase 1

Arthritis, Psoriatic | Small molecule | Immunology |Roche Holding AG|Last Updated: Oct 27, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

RO5310074 · 1 trial · 1 indication

Phase 1 1
NCT01199809A Study of RO5310074 in Patients With Psoriatic ArthritisArthritis, Psoriatic
COMPLETED19 Analytics
PHASE1COMPLETED
A Study of RO5310074 in Patients With Psoriatic Arthritis
Arthritis, PsoriaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
25 weeks

Secondary Endpoints

Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL)
12 weeks
Pharmacodynamics (anti-drug-antibodies)
25 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGmultiple doses
RO5310074DRUGmultiple ascending doses
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Adult patients, 18 - 75 years of age * Diagnosis of Psoriatic Arthritis (Moll and Wright or CASPAR criteria) of \>/= 6 months duration * Have \>/= 3 swollen and \>/= 3 tender joints * Inadequate response to a current or previous oral DMARD or NSAID therapy * Current oral DMARD...

Countries:United StatesAustraliaNew Zealand
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Frequently asked questions about RO5310074

What is RO5310074 used for?

RO5310074 is an investigational small molecule being developed for the treatment of psoriatic arthritis. It is being studied in patients with this condition, and the clinical trial for this indication has been completed.

Who makes RO5310074?

RO5310074 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is investigating this small molecule for the treatment of psoriatic arthritis.

What phase is RO5310074 in?

RO5310074 is in Phase 1 clinical development. A Phase 1 study in patients with psoriatic arthritis has been completed, and the drug remains investigational, meaning it is not yet approved for any use.

What clinical trials is RO5310074 in?

RO5310074 has one completed clinical trial, identified as NCT01199809, titled "A Study of RO5310074 in Patients With Psoriatic Arthritis." This Phase 1 study enrolled 19 participants and was conducted in the United States, Australia, and New Zealand.

Is RO5310074 FDA approved?

RO5310074 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for psoriatic arthritis, but it has not received approval from the FDA or any other regulatory authority.