NCT01618968

Brief Summary

Relative Bioavailability Comparison study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

June 4, 2012

Results QC Date

February 27, 2014

Last Update Submit

May 8, 2014

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (3)

  • Dose-Normalized AUC[0-Inf] for MTX

    Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment

    24 Hour period

  • Dose-Normalized AUC[0-24] for MTX

    Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment

    24 Hour period

  • Dose-Normalized Cmax for MTX

    Dose-normalized maximum observed concentration (Cmax) for each treatment

    24 Hour period

Study Arms (4)

10 mg Methotrexate (MTX)

EXPERIMENTAL

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Drug: MTX

15 mg MTX

EXPERIMENTAL

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Drug: MTX

20 mg MTX

EXPERIMENTAL

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Drug: MTX

25 mg MTX

EXPERIMENTAL

MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.

Drug: MTX

Interventions

MTXDRUG

* Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group) * Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) * Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)

Also known as: Commercially available 2.5 mg MTX oral tablets, VIBEX MTX
10 mg Methotrexate (MTX)15 mg MTX20 mg MTX25 mg MTX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis

You may not qualify if:

  • Pregnant females
  • Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (1)

  • Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014 Aug;73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.

    PMID: 24728329DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Jonathan Jaffe, MD; Vice President Clinical Development
Organization
Antares Pharma Inc.
jjaffe@antarespharma.com
609-359-3020

Study Officials

  • Alan J Kivitz, MD;CPI

    Altoona Center for Clinical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 14, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 19, 2014

Results First Posted

May 8, 2014

Record last verified: 2014-05

Locations

US(1)