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Co-Administration Of Methotrexate And CP-690,550

Last updated on October 4, 2018

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Study Location
Pfizer Investigational Site
Daytona Beach, Florida, 32114 United States
Contact
1-800-718-1021
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 blood cell count

- 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.

NCT01745055
Pfizer
Completed
Co-Administration Of Methotrexate And CP-690,550

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Co-Administration Of Methotrexate And CP-690,550
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Rheumatoid Arthritis
  • Drug: CP-690,550 (tofacitinib)
    CP-690,550 30 mg q12h for 5 days
  • Drug: Methotrexate (MTX)
    individual dose of methotrexate (stably dosed)
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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2006
June 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01745055
A3921013
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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