NCT01450982

Brief Summary

The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

4 active sites

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

June 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

First QC Date

June 13, 2011

Last Update Submit

May 3, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisJNJ-38518168Methotrexate

Outcome Measures

Primary Outcomes (1)

  • Blood levels of methotrexate

    To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate

    Up to approximately 7 weeks

Secondary Outcomes (4)

  • Blood levels of JNJ-38518168

    Up to approximately 7 weeks

  • The number of participants with adverse events

    Up to approximately 7 weeks

  • Clinical laboratory tests

    Up to approximately 7 weeks

  • Electrocardiograms

    Up to approximately 7 weeks

Study Arms (1)

001

EXPERIMENTAL

JNJ-38518168 / MTX Day 1: MTX: Route=oral use single dose of participant's weekly MTX dose Days 2-15: MTX: Route=oral use single dose of participant's weekly MTX dose and of JNJ-38518168 Type=exact unit=mg number=100 form=capsule route=oral use administered daily.

Drug: JNJ-38518168 / MTX

Interventions

JNJ-38518168 / MTXDRUG

Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose

001

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a body mass index (BMI) between 18 and 38 kg/m2 inclusive, and a body weight between 50-110 kg, inclusive
  • Have a diagnosis of Rheumatoid Arthritis functional class I-III for at least 3 months prior to Screening
  • Have been treated with and tolerated oral MTX treatment for a minimum of 3 months prior to screening and must have been on a once-weekly stable MTX dose (taken as a single dose) (between 7.5-25 mg/week) for a minimum of 1 month
  • Participants may continue on stable non-steroid anti-inflammatory drugs and corticosteroid background therapy for RA or stable therapies for other conditions as prescribed by physician, provided that the doses of such therapy are stable for at least 1 month prior to screening and will remain unchanged for the entire study duration.

You may not qualify if:

  • Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the study doctor's opinion
  • Have been treated with a monoclonal antibody for RA or have had a serious infection with 2 weeks of the study treatment period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Anniston, Alabama, United States

Location

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2011

First Posted

October 13, 2011

Study Start

June 1, 2011

Study Completion

October 1, 2011

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

US(4)