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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01484561 |
Recruitment Status :
Completed
First Posted : December 2, 2011
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science |
Condition |
Arthritis, Rheumatoid |
Interventions |
Drug: CP-690,550 or Placebo Drug: Placebo |
Enrollment | 148 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | CP-690,550/Placebo | Placebo/Placebo |
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Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2 | Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days) |
Period Title: Overall Study | ||
Started | 97 | 51 |
Completed | 88 | 45 |
Not Completed | 9 | 6 |
Reason Not Completed | ||
Lack of Efficacy | 3 | 1 |
Lost to Follow-up | 1 | 0 |
Withdrawal by Subject | 3 | 0 |
Other | 1 | 1 |
Adverse Event | 1 | 4 |
Baseline Characteristics
Arm/Group Title | CP-690,550/Placebo | Placebo/Placebo | Total | |
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Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2 | Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days) | Total of all reporting groups | |
Overall Number of Baseline Participants | 97 | 51 | 148 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 97 participants | 51 participants | 148 participants | |
51.9 (12.7) | 47.3 (11.8) | 50.3 (12.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 97 participants | 51 participants | 148 participants | |
Female |
75 77.3%
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36 70.6%
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111 75.0%
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Male |
22 22.7%
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15 29.4%
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37 25.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01484561 |
Other Study ID Numbers: |
A3921152 |
First Submitted: | November 30, 2011 |
First Posted: | December 2, 2011 |
Results First Submitted: | January 11, 2014 |
Results First Posted: | April 2, 2014 |
Last Update Posted: | April 2, 2014 |