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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-690,550 (tofacitinib) 30 mg q12h | Experimental | Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 (tofacitinib) | Drug | CP-690,550 30 mg q12h for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550 | AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12). | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
| Maximum Observed Plasma Concentration (Cmax) for CP-690,550 | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7 |
| Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX) | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550 | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 | |
| Plasma Decay Half-Life (t1/2) for CP-690,550 | Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Daytona Beach | Florida | 32114 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methotrexate + CP-690,550 | Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Methotrexate + CP-690,550 | Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550 | AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12). | The pharmacokinetic (PK) analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methotrexate | Single oral dose of MTX on Day 1 (15-25 mg), as per local prescribing practice. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
Results were summarized for Ae(0-12) instead of planned Ae(0-24), as CP-690,550 was administered every 12 hours.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate (MTX) |
| Drug |
individual dose of methotrexate (stably dosed) |
|
| 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
| Apparent Oral Clearance (CL/F) for CP-690,550 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX) | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 ,12, 24 and 48 hours post-dose on Day 1 and Day 7 |
| Plasma Decay Half-Life (t1/2) for Methotrexate (MTX) | Plasma decay half-life is the time measured for the plasma concentration of MTX to decrease by one half. | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7 |
| Apparent Oral Clearance (CL/F) for Methotrexate (MTX) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7 |
| Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550 | 0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7 |
| Renal Clearance (CL R) for CP-690,550 | 0 (pre-dose) through 24 hours post-dose on Day 6 and Day 7 |
| Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX) | 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7 |
| Renal Clearance (CL R) for Methotrexate (MTX) | 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7 |
| Fort Lauderdale |
| Florida |
| 33301 |
| United States |
| Pfizer Investigational Site | Miramar | Florida | 33025 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75247 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for CP-690,550 | The PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | ng/mL | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
|
|
|
|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7 |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX) | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | ng/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7 |
|
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550 | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Median | Full Range | hour | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
|
|
|
| Secondary | Plasma Decay Half-Life (t1/2) for CP-690,550 | Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half. | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | hour | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) for CP-690,550 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | mL/hr | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7 |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX) | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Median | Full Range | hour | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 ,12, 24 and 48 hours post-dose on Day 1 and Day 7 |
|
|
|
| Secondary | Plasma Decay Half-Life (t1/2) for Methotrexate (MTX) | Plasma decay half-life is the time measured for the plasma concentration of MTX to decrease by one half. | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | hour | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7 |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) for Methotrexate (MTX) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | mL/hr | 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7 |
|
|
|
| Secondary | Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550 | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | milligram | 0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7 |
|
|
|
| Secondary | Renal Clearance (CL R) for CP-690,550 | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | litre/hour (L/hr) | 0 (pre-dose) through 24 hours post-dose on Day 6 and Day 7 |
|
|
|
| Secondary | Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX) | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | milligram | 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7 |
|
|
|
| Secondary | Renal Clearance (CL R) for Methotrexate (MTX) | PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence. | Posted | Mean | Standard Deviation | L/hr | 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7 |
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | CP-690,500 | CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6. | 0 | 12 | 6 | 12 |
| EG002 | Methotrexate + CP-690,500 | Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7. | 0 | 12 | 5 | 12 |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Migrane | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |