A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01484561
First received: November 30, 2011
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Drug: CP-690,550 or Placebo Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in measured glomerular filtration rate (as determined by iohexol serum clearance) at the end of Period 1 from baseline. [ Time Frame: End of Period 1, approximately Day 43 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in measured glomerular filtration rate (mGFR) at the end of Period 2 from baseline. [ Time Frame: End of Period 2, approximately Day 72 ] [ Designated as safety issue: Yes ]
- Change in mGFR at the end of Period 2 from the end of Period 1. [ Time Frame: End of Period 2, approximately Day 29 ] [ Designated as safety issue: Yes ]
- Change in estimated glomerular filtration rate (eGFR) from baseline to the end of Period 1. [ Time Frame: End of Period 1, approximately Day 43 ] [ Designated as safety issue: Yes ]
- Change in eGFR from baseline to the end of Period 2. [ Time Frame: End of Period 2, approximately Day 72 ] [ Designated as safety issue: Yes ]
- Change in serum creatinine from baseline to the end of Period 1. [ Time Frame: End of Period 1, approximately Day 43 ] [ Designated as safety issue: Yes ]
- Change in serum creatinine from baseline to the end of Period 2. [ Time Frame: End of Period 2, approximately Day 72 ] [ Designated as safety issue: Yes ]
- American College of Rheumatology (ACR) 20/50/70 and Disease Activity Score 28 joint count and using C-Reactive Protein (DAS28 [CRP]) at end of Period 1. [ Time Frame: End of Period 1, approximately Day 43 ] [ Designated as safety issue: No ]
- ACR20/50/70 and DAS28 (CRP) at end of Period 2. [ Time Frame: End of Period 2, approximately Day 72 ] [ Designated as safety issue: No ]
| Enrollment: | 147 |
| Study Start Date: | April 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Sequence 1 |
Drug: CP-690,550 or Placebo
CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days
|
| Placebo Comparator: Sequence 2 |
Drug: Placebo
Placebo BID orally, approximately 72 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484561
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| South Miami, Florida, United States, 33143 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Albany, New York, United States, 12206 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Praha 4, Czech Republic, 140 59 | |
| Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13125 | |
| Pfizer Investigational Site | |
| Erlangen, Germany, 91054 | |
| Pfizer Investigational Site | |
| Wuerzburg, Germany, 97080 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 120-752 | |
| Mexico | |
| Pfizer Investigational Site | |
| Merida, Yucatan, Mexico, 97000 | |
| Poland | |
| Pfizer Investigational Site | |
| Bialystok, Poland, 15-354 | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85-168 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 01-192 | |
| Pfizer Investigational Site | |
| Wroclaw, Poland, 50-088 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115522 | |
| Pfizer Investigational Site | |
| Petrozavodsk, Russian Federation, 185019 | |
| Pfizer Investigational Site | |
| Saint Petersburg, Russian Federation, 197341 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 194291 | |
| Spain | |
| Pfizer Investigational Site | |
| Barakaldo, Vizcaya, Spain, 48903 | |
| Pfizer Investigational Site | |
| Bilbao, Vizcaya, Spain, 48013 | |
| Pfizer Investigational Site | |
| A Coruna, Spain, 15006 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41009 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01484561 History of Changes |
| Other Study ID Numbers: | A3921152 |
| Study First Received: | November 30, 2011 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 1 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013