Phase 1
Completed N=148
A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT01484561 ↗
Enrolled (actual)
148
Serious AEs
1.4%
Results posted
Apr 2014
Primary outcomePrimary: Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) — 0.91; 0.99 fold change
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) |
0.91; 0.99 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR |
0.96; 0.92 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR |
1.03; 0.95 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD) |
0.96; 1.01 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD |
0.99; 1.01 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD |
1.04; 1.00 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation |
0.96; 1.01 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation |
1.00; 1.01 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation |
1.03; 1.00 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine |
1.04; 0.99 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine |
1.00; 1.00 | — |
| SECONDARY Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine |
0.97; 1.00 | — |
| SECONDARY Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response |
57.73; 21.57; 45.36; 29.41 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
28.87; 7.84; 26.80; 9.80 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
18.56; 0.00; 9.28; 1.96 | <0.001 sig |
| SECONDARY Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP]) |
-1.71; -0.55 | <0.001 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP) |
-1.36; -0.89 | 0.028 sig |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP) |
0.35; -0.34 | 0.002 sig |
| SECONDARY LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP) |
-1.88; -0.62 | <0.001 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP) |
-1.46; -0.96 | 0.031 sig |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP) |
0.42; -0.34 | 0.002 sig |
| SECONDARY LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count |
-9.88; -5.79 | 0.045 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count |
-8.13; -8.27 | 0.936 |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count |
1.75; -2.48 | 0.030 sig |
| SECONDARY LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count |
-7.07; -4.81 | 0.030 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count |
-6.63; -5.83 | 0.472 |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count |
0.43; -1.02 | 0.158 |
| SECONDARY LS Mean Change at End of Period 1 From Baseline in CRP |
-13.81; -0.08 | <0.001 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline in CRP |
-8.37; 0.53 | 0.029 sig |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 in CRP |
5.44; 0.61 | 0.107 |
| SECONDARY LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA) |
-23.28; -7.38 | 0.001 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline in PGAA |
-16.12; -10.41 | 0.251 |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 in PGAA |
7.16; -3.03 | 0.023 sig |
| SECONDARY LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis |
-29.83; -14.71 | <0.001 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis |
-24.61; -22.21 | 0.616 |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis |
5.22; -7.50 | 0.003 sig |
| SECONDARY LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain |
-23.53; -8.23 | <0.001 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain |
-14.70; -9.08 | 0.247 |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain |
8.83; -0.85 | 0.040 sig |
| SECONDARY LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score |
-0.44; -0.04 | <0.001 sig |
| SECONDARY LS Mean Change at End of Period 2 From Baseline HAQ-DI Score |
-0.34; -0.17 | 0.053 |
| SECONDARY LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score |
0.09; -0.13 | 0.003 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01484561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.