Phase 1
Completed N=12
Co-Administration Of Methotrexate And CP-690,550
Source: ClinicalTrials.gov NCT01745055 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550 — 1370; 1410 nanogram*hour/milliliter (ng*hr/mL)
Summary
This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 and MTX.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550 |
1370; 1410 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for CP-690,550 |
375; 384 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX) |
1850; 1720 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX) |
478; 433 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550 |
1.00; 1.00 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) for CP-690,550 |
2.64; 3.12 | — |
| SECONDARY Apparent Oral Clearance (CL/F) for CP-690,550 |
23200; 23511 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX) |
1.00; 1.25 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) for Methotrexate (MTX) |
2.87; 3.36 | — |
| SECONDARY Apparent Oral Clearance (CL/F) for Methotrexate (MTX) |
9890; 11500 | — |
| SECONDARY Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550 |
6.65; 6.58 | — |
| SECONDARY Renal Clearance (CL R) for CP-690,550 |
5490; 5240 | — |
| SECONDARY Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX) |
18.1; 13.2 | — |
| SECONDARY Renal Clearance (CL R) for Methotrexate (MTX) |
10.2; 8.95 | — |
Eligibility Criteria
Inclusion Criteria
- Adults diagnosed with moderate to severe RA (Rheumatoid Arthritis)
- Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
- Treatment with an oral stable weekly dose of Methotrexate (MTX) (15-25 mg/week, administered as a single dose [SD]) for a minimum of 4 doses (4 weeks)
Exclusion Criteria
- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
- Evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
- Total bilirubin, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) more than 1.2 times the upper limit of normal at the Screening visit, or a history of clinically significant elevated liver function tests (LFTs) while on current MTX dose or chronic liver disease, recent or active hepatitis.
Data sourced from ClinicalTrials.gov (NCT01745055). 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.