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PD 0360324

Phase 1

Arthritis, Rheumatoid | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Jul 14, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

PD 0360324 · 1 trial · 1 indication

Phase 1 1
NCT00550355Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid ArthritisArthritis, Rheumatoid
COMPLETED78 Analytics
PHASE1COMPLETED
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Arthritis, RheumatoidUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical safety laboratories
16 weeks
Vital signs
16 weeks
ECG
16 weeks
Incidence and severity of adverse events
16 weeks

Secondary Endpoints

Pharmacokinetic
16 weeks
Pharmacodynamic
16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PD 0360324DRUG3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
PlaceboDRUG3 doses of Placebo administered over 12 weeks
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Eligibility Criteria

Age Range21 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Diagnosis of RA for at least 6 months based upon the American College of Rheumatology (ACR) 1987 Revised Criteria. * Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. The dose of methotrexate must be s...

Countries:United StatesArgentinaBulgariaCzechiaMexicoPolandSlovakiaSpain
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Frequently asked questions about PD 0360324

What is PD 0360324 used for?

PD 0360324 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is being studied in combination with methotrexate in patients with this condition. The drug is currently in Phase 1 clinical development and is not yet approved for any use.

Who makes PD 0360324?

PD 0360324 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for rheumatoid arthritis.

What phase is PD 0360324 in?

PD 0360324 is in Phase 1 clinical development. It is an investigational drug being studied for rheumatoid arthritis and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed.

What clinical trials is PD 0360324 in?

PD 0360324 has one completed clinical trial, NCT00550355, a dose-escalating multiple dose study of PD-0360324 in combination with methotrexate in patients with rheumatoid arthritis. The trial enrolled 78 participants across the United States, Argentina, Bulgaria, Czechia, Mexico, Poland, Slovakia, and Spain.

Is PD 0360324 FDA approved?

PD 0360324 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for rheumatoid arthritis. The drug has completed one early-stage clinical trial, but it remains under study and has not been approved for any medical use.