NCT01442545

Brief Summary

The purpose of this study is to evaluate the effects of JNJ-39758979 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
2 countries

5 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

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

First QC Date

August 23, 2011

Last Update Submit

March 12, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisJNJ-39758979Methotrexate

Outcome Measures

Primary Outcomes (1)

  • Blood levels of methotrexate

    To assess the effect of multiple doses of JNJ-39758979 on blood levels of methotrexate

    Up to approximately 7 weeks

Secondary Outcomes (4)

  • Blood levels of JNJ 39758979

    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
Drug: JNJ-39758979 / MTX

Interventions

JNJ-39758979 / MTXDRUG

Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose; Days 3-15: MTX: Route=oral use, single dose of participant's weekly MTX dose and JNJ 39758979: Type=exact, unit=mg, number=300, form=tablet, route=oral use, administered daily.

001

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Rheumatoid Arthritis Functional Class I-III according to the American College of Rheumatology criteria for at least 3 months prior to Screening
  • Have been treated with and tolerated oral methotrexate (taken by mouth) for a minimum of 3 months prior to screening, and must have been on a stable once-weekly methotrexate dose (taken as a single dose) between 7.5 and 25 mg/week for a minimum of 1 month prior to Day 1
  • Participants may continue on stable nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroid background therapy for rheumatoid arthritis (RA) or stable therapies for other conditions as prescribed by physician, providing 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
  • Medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening
  • Laboratory values within certain limits at screening and Day-1. Abnormalities consistent with those observed in patients with RA are permissible.

You may not qualify if:

  • History of or current clinically significant medical illness as specified on the protocol, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Have been treated with a monoclonal antibody for RA in the 3 months prior to enrollment or have had a serious infection within 2 weeks of the study treatment period
  • Except for methotrexate, treated with approved or investigational non-biologic disease-modifying antirheumatic drugs (DMARDs) during the 4 weeks or 5 half-lives prior to the first dose of JNJ-39758979, whichever is longer. These agents include, but are not limited to D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine, leflunomide, azathioprine, cyclosporine, tacrolimus and mycophenolate mofetil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Munich, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • J&J 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

August 23, 2011

First Posted

September 28, 2011

Study Start

August 1, 2011

Study Completion

December 1, 2011

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

DE(2)US(3)