Rheumatoid ArthritisPhase 1NCT01745055

Co-Administration Of Methotrexate And CP-690,550

A Phase 1 study testing CP-690,550 (tofacitinib) and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Pfizer at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: CP-690,550 (tofacitinib) and Methotrexate (MTX)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 4 sitesUnited States
Study dates: Apr 2005to Jun 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Pfizer Investigational Site
Dallas, Texas, 75247
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Fort Lauderdale, Florida, 33301
Pfizer Investigational Site
Miramar, Florida, 33025

Other trials in United States

About this study

Official title: A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects

Conditions: Rheumatoid Arthritis
Being tested: CP-690,550 (tofacitinib), Methotrexate (MTX)
Keywords: Pharmacokinetics, oral JAK inhibitor, methotrexate (MTX), rheumatoid arthritis (RA)
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP-690,550 (tofacitinib)Drug
CP-690,550 30 mg q12h for 5 days
Methotrexate (MTX)Drug
individual dose of methotrexate (stably dosed)

Study groups in NCT01745055
Study group	Role	What they receive
CP-690,550 (tofacitinib) 30 mg q12h	Experimental	Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h Receives: Drug: CP-690,550 (tofacitinib); Drug: Methotrexate (MTX)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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 outcomes (10)

Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7
Renal Clearance (CL R) for CP-690,550
Measured: 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)
Measured: 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7
Renal Clearance (CL R) for Methotrexate (MTX)
Measured: 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Jun 2006

First posted7 Dec 2012 (estimated)
Study startApr 2005
Primary completionJun 2006
Study completionJun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01745055
Sponsor's protocol ID: A3921013
Status last verified: Jan 2013
First submitted: 4 Dec 2012
Last updated: 4 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects
ClinicalTrials.gov ID: NCT01745055
Acronym / sponsor ID: A3921013
Conditions: Rheumatoid Arthritis
Keywords: Pharmacokinetics, oral JAK inhibitor, methotrexate (MTX), rheumatoid arthritis (RA)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Jun 2006 (actual)
Study completion: Jun 2006 (actual)
First posted: 7 Dec 2012 (estimated)
Results: Posted 7 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CP-690,550 (tofacitinib) 30 mg q12h	Experimental	Drug: CP-690,550 (tofacitinib), Drug: Methotrexate (MTX)Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CP-690,550 (tofacitinib)CP-690,550 30 mg q12h for 5 days	Drug	CP-690,550 (tofacitinib) 30 mg q12h
Methotrexate (MTX)individual dose of methotrexate (stably dosed)	Drug	CP-690,550 (tofacitinib) 30 mg q12h

Primary outcome

Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7
AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12).
Maximum Observed Plasma Concentration (Cmax) for CP-690,550
Time frame: 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)
Time frame: 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
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)
Time frame: 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

10 secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7
Renal Clearance (CL R) for CP-690,550
Time frame: 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)
Time frame: 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7
Renal Clearance (CL R) for Methotrexate (MTX)
Time frame: 0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7

Results and safety

Results posted to the registry on 7 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methotrexate + CP-690,550	12	12

Primary outcome: Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7. Mean (Standard Deviation). Unit: nanogram*hour/milliliter (ng*hr/mL)

Measure	CP-690,500 n = 12	Methotrexate + CP-690,500 n = 12
Value	1370 (423)	1410 (425)

CP-690,500 vs Methotrexate + CP-690,500: Ratio of Adjusted Geometric Means: 103.06 (90% CI 99.00 to 107.29)

Population analysed: The pharmacokinetic (PK) analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for CP-690,550

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7. Mean (Standard Deviation). Unit: ng/mL

Measure	CP-690,500 n = 12	Methotrexate + CP-690,500 n = 12
Value	375 (91.6)	384 (84.8)

CP-690,500 vs Methotrexate + CP-690,500: Ratio of Adjusted Geometric Means: 102.71 (90% CI 93.79 to 112.47)

Population analysed: The PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.

Primary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX)

Time frame: 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. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Methotrexate n = 12	Methotrexate + CP-690,500 n = 12
Value	1850 (685)	1720 (753)

Methotrexate vs Methotrexate + CP-690,500: Ratio of Adjusted Geometric Means: 89.53 (90% CI 77.38 to 103.57)

Population analysed: PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)

Time frame: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Methotrexate n = 12	Methotrexate + CP-690,500 n = 12
Value	478 (106)	433 (175)

Methotrexate vs Methotrexate + CP-690,500: Ratio of Adjusted Geometric Means: 87.25 (90% CI 76.03 to 100.12)

Population analysed: PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methotrexate	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
CP-690,500	0 of 12 (0%)	6 of 12 (50%)	Not reported
Methotrexate + CP-690,500	0 of 12 (0%)	5 of 12 (41.7%)	Not reported

Limitations and caveats (from the sponsor): Results were summarized for Ae(0-12) instead of planned Ae(0-24), as CP-690,550 was administered every 12 hours.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CP-690,550 (tofacitinib) and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Pfizer at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550 (time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01745055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.