Phase 2 N=36 Randomized Treatment

Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01737944 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX — 118.14; 122.63; 116.71 ng*hr/mL/mg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Methotrexate (MTX) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Antares Pharma Inc.
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX	118.14; 122.63; 116.71	—
PRIMARY Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX	116.60; 121.08; 122.63	—
PRIMARY Bioequivalence Based Upon Dose-Normalized Cmax for MTX	21.43; 22.38; 23.37	—

Summary

Pharmacokinetics (PK) study

Eligibility Criteria

Inclusion Criteria

Male or female >18 years of age with diagnosed Rheumatoid Arthritis(RA).

Exclusion Criteria

Chronic or acute renal disease
Any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01737944). 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.