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PRO283698

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Roche Holding AG|Last Updated: Dec 1, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

PRO283698 · 1 trial · 1 indication

Phase 1 1
NCT00888745A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED65 Analytics
PHASE1COMPLETED
A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of PRO283698 assessed through the incidence of adverse events
Through study completion or early study discontinuation

Secondary Endpoints

Pharmacokinetic parameters
Following study drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
placeboDRUGIntravenous and subcutaneous ascending dose
PRO283698DRUGIntravenous and subcutaneous ascending dose
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * RA diagnosed according to the American College of Rheumatology (ACR) Exclusion Criteria: * Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding * Clinically significant abnormal ECG * History of anaphylactic reactions * Positive he...

Countries:United StatesHungary
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Frequently asked questions about PRO283698

What is PRO283698 used for?

PRO283698 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and pharmacokinetics in patients with this condition.

Who makes PRO283698?

PRO283698 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The company is conducting clinical research to evaluate the drug's potential in treating rheumatoid arthritis.

What phase is PRO283698 in?

PRO283698 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains under evaluation for its safety and pharmacokinetic profile in patients with rheumatoid arthritis.

What clinical trials is PRO283698 in?

PRO283698 has one completed Phase 1 clinical trial registered as NCT00888745. This study, titled 'A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis,' enrolled 65 participants across the United States and Hungary. The trial was randomized, double-blind, and placebo-controlled.

Is PRO283698 FDA approved?

PRO283698 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for rheumatoid arthritis. The drug has completed a Phase 1 trial, but it has not yet progressed through the later stages of clinical testing required for regulatory approval.

What is the mechanism of action of PRO283698?

The specific molecular target of PRO283698 has not been disclosed in available information. As a small molecule being studied for rheumatoid arthritis, it is presumed to modulate pathways involved in the inflammatory process, but its exact mechanism of action remains under investigation in clinical trials.