Co-Administration Of Methotrexate And CP-690,550

NCT01745055

Last updated date
Study Location
Pfizer Investigational Site
Daytona Beach, Florida, 32114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults diagnosed with moderate to severe RA (Rheumatoid Arthritis)

- Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.

- Treatment with an oral stable weekly dose of Methotrexate (MTX) (15-25 mg/week, administered as a single dose [SD]) for a minimum of 4 doses (4 weeks)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
<100 x 109/L


- Evidence or history of clinically significant infections within the past 6 months (eg,
those requiring hospitalization, requiring parenteral antimicrobial therapy, or those
with recurrent oral or genital herpes, recurrent herpes zoster, or any infection
otherwise judged by the investigator to have the potential for exacerbation by
participation in the trial.


- Total bilirubin, AST (aspartate aminotransferase) or ALT (alanine aminotransferase)
more than 1.2 times the upper limit of normal at the Screening visit, or a history of
clinically significant elevated liver function tests (LFTs) while on current MTX dose
or chronic liver disease, recent or active hepatitis.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Co-Administration Of Methotrexate And CP-690,550
Official Title  ICMJE A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects
Brief Summary This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 and MTX.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CP-690,550 (tofacitinib)
    CP-690,550 30 mg q12h for 5 days
  • Drug: Methotrexate (MTX)
    individual dose of methotrexate (stably dosed)
Study Arms  ICMJE Experimental: CP-690,550 (tofacitinib) 30 mg q12h
Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h
Interventions:
  • Drug: CP-690,550 (tofacitinib)
  • Drug: Methotrexate (MTX)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2012)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults diagnosed with moderate to severe RA (Rheumatoid Arthritis)
  • Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
  • Treatment with an oral stable weekly dose of Methotrexate (MTX) (15-25 mg/week, administered as a single dose [SD]) for a minimum of 4 doses (4 weeks)

Exclusion Criteria:

  • Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
  • Evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
  • Total bilirubin, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) more than 1.2 times the upper limit of normal at the Screening visit, or a history of clinically significant elevated liver function tests (LFTs) while on current MTX dose or chronic liver disease, recent or active hepatitis.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01745055
Other Study ID Numbers  ICMJE A3921013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP