Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: PD 0360324; Drug: Placebo

• Registration Number: NCT00550355
• Lead Sponsor: Pfizer

Brief Summary

This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-29
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-13
• Last Update Posted: 2009-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 stable for at least 6 weeks prior to enrollment.
• Females of childbearing potential are required to simultaneously use 2 effective contraceptive methods, 1 of which must be a barrier (condoms, diaphragm or cervical cap) with spermicide. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures
• Contact your local site for more inclusion criteria.

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Exclusion Criteria

• Diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies); or a non-inflammatory arthritis or musculoskeletal condition (eg, osteoarthritis, fibromyalgia) that, in the investigator's opinion, may interfere with clinical assessments.
• Evidence of active or latent infection with Mycobacterium tuberculosis (TB).
• Use of etanercept, anakinra, or oral DMARDs with the exception of methotrexate, within the 4 weeks prior to enrollment. Use of biological DMARDs within the 8 (adalimumab or infliximab) or 12 (abatacept) or 56 (rituximab) weeks prior to enrollment. Use of oral corticosteroids, acetaminophen, NSAIDs, and opioids are permitted within the dose ranges defined in the protocol.
• Contact your local site for more inclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	PD 0360324	-
3	PD 0360324	-
4	Placebo	-
1	PD 0360324	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic	16 weeks
Pharmacodynamic	16 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Santiago de Compostela, A Coruña, Spain