You are here

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

Last updated on November 8, 2019

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
Official Title  ICMJE 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
Brief SummaryThe 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).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Sequence 1
    Intervention: Drug: CP-690,550 or Placebo
  • Placebo Comparator: Sequence 2
    Intervention: Drug: Placebo
Publications *


*   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: March 4, 2014)
148
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2011)
132
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion DateJanuary 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Czech Republic,   Germany,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01484561
Other Study ID Numbers  ICMJE A3921152
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now