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

• ClinicalTrials.gov Identifier: NCT00550355
• Recruitment Status: Completed
• First Posted: October 29, 2007
• Last Update Posted: July 14, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: October 25, 2007
• First Posted Date: October 29, 2007
• Last Update Posted Date: July 14, 2009
• Study Start Date: August 2007
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 23, 2008)

• 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 ]

Original Primary Outcome Measures (submitted: October 25, 2007)

• Incidence and severity of adverse events
• physical exams
• Clinical safety laboratories
• Vital signs
• ECG in patients receiving PD 0360324 relative to placebo throughout the study

• Change History: Complete list of historical versions of study NCT00550355 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: December 19, 2007)

• Pharmacokinetic [ Time Frame: 16 weeks ]
• Pharmacodynamic [ Time Frame: 16 weeks ]

• Original Secondary Outcome Measures (submitted: October 25, 2007): Multiple dose pharmacokinetic and pharmacodynamic profile of intravenously administered PD 0360324 determined throughout the study
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid

Intervention

• Drug: PD 0360324
  3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
• Drug: PD 0360324
  3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
• Drug: PD 0360324
  3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
• Drug: Placebo
  3 doses of Placebo administered over 12 weeks

Study Arms

• Experimental: 1
  Intervention: Drug: PD 0360324
• Experimental: 2
  Intervention: Drug: PD 0360324
• Experimental: 3
  Intervention: Drug: PD 0360324
• Placebo Comparator: 4
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2009): 78
• Original Enrollment (submitted: October 25, 2007): 60
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Bulgaria, Czech Republic, Mexico, Poland, Slovakia, Spain, United States

Administrative Information

• NCT Number: NCT00550355
• Other Study ID Numbers: A6261002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2009