NCT00550355CompletedPhase 1
A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Clinical safety laboratories
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
1
Experimental
Intervention: PD 0360324 (Drug)
2
Experimental
Intervention: PD 0360324 (Drug)
3
Experimental
Intervention: PD 0360324 (Drug)
4
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Clinical safety laboratories
Time Frame: 16 weeks
Vital signs
Time Frame: 16 weeks
ECG
Time Frame: 16 weeks
Incidence and severity of adverse events
Time Frame: 16 weeks
Secondary Outcomes
- Pharmacokinetic(16 weeks)
- Pharmacodynamic(16 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Phase 1
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus ErythematosusCutaneous Lupus ErythematosusNCT01470313Pfizer28
Recruiting
Phase 1
Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-101 in Participants With Myotonic Dystrophy Type 1Myotonic Dystrophy Type 1 (DM1)NCT05481879Dyne Therapeutics116
Completed
Phase 1
A Clinical Study to Assess Single and Repeat Doses of a New Medication (GSK933776) in Patients With Alzheimer's DiseaseAlzheimer's DiseaseNCT00459550GlaxoSmithKline50
Completed
Phase 1
An Ascending Multi-Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic VolunteersObesityDiabetes MellitusNCT00806338Genaera Corporation22
Completed
Phase 1
FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy SubjectsHealthy VolunteersNCT05905913Antabio72