A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate

• ClinicalTrials.gov Identifier: NCT00620685
• Recruitment Status: Completed
• First Posted: February 21, 2008
• Last Update Posted: November 8, 2018
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: January 10, 2008
• First Posted Date: February 21, 2008
• Last Update Posted Date: November 8, 2018
• Study Start Date: March 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 7, 2008): Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings [ Time Frame: 6 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00620685 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: February 7, 2008): Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX [ Time Frame: 6 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate
• Official Title: A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate
• Brief Summary: The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid

Intervention

• Drug: Placebo
  Tablet, once daily for 4 weeks
• Drug: PH-797804
  Tablet, 1 mg PH-797804, once daily for 4 weeks
• Drug: PH-797804
  Tablet, 5 mg PH-797804, once daily for 4 weeks

Study Arms

• Placebo Comparator: 1
  Intervention: Drug: Placebo
• Experimental: 2
  Intervention: Drug: PH-797804
• Experimental: 3
  Intervention: Drug: PH-797804

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2008): 27
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adult with RA for at least 6 months
• Stable weekly dosage of oral methotrexate 12.5- 25 mg/week

Exclusion Criteria:

• Severe, progressive and/or uncontrolled other disease
• Chronic or recent serious infection; current infection
• Concomitant use of RA therapy other than methotrexate with some exceptions

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00620685
• Other Study ID Numbers: A6631005
• 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: November 2018