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A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
South Miami, Florida, 33143 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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The patient must meet the American College of Rheumatology (ACR) classification
criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the
seven criteria.

- The patient must have active disease at both Screening and predose on Day 1 of Period
1.

- Patient must have had an inadequate response to at least one disease-modifying
antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or
intolerance.

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

- Pregnant or lactating women

- Serious medical conditions that would make treatment with CP-690,550 potentially
unsafe.

- A patient who has a history of asthma, multiple allergies or severe allergy (eg,
anaphylaxis) to any substance. In particular, a history of allergy to iodine,
povidone-iodine, iohexol or other iodinated contrast media.

NCT01484561
Pfizer
Completed
A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

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A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis
The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Arthritis, Rheumatoid
  • Drug: CP-690,550 or Placebo
    CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days
  • Drug: Placebo
    Placebo BID orally, approximately 72 days
  • Active Comparator: Sequence 1
    Intervention: Drug: CP-690,550 or Placebo
  • Placebo Comparator: Sequence 2
    Intervention: Drug: Placebo
Kremer JM, Kivitz AJ, Simon-Campos JA, Nasonov EL, Tony HP, Lee SK, Vlahos B, Hammond C, Bukowski J, Li H, Schulman SL, Raber S, Zuckerman A, Isaacs JD. Evaluation of the effect of tofacitinib on measured glomerular filtration rate in patients with active rheumatoid arthritis: results from a randomised controlled trial. Arthritis Res Ther. 2015 Apr 6;17:95. doi: 10.1186/s13075-015-0612-7.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
February 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the seven criteria.
  • The patient must have active disease at both Screening and predose on Day 1 of Period 1.
  • Patient must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or intolerance.

Exclusion Criteria:

  • Pregnant or lactating women
  • Serious medical conditions that would make treatment with CP-690,550 potentially unsafe.
  • A patient who has a history of asthma, multiple allergies or severe allergy (eg, anaphylaxis) to any substance. In particular, a history of allergy to iodine, povidone-iodine, iohexol or other iodinated contrast media.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Spain,   United States
 
 
NCT01484561
A3921152
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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