A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01450982
First received: June 13, 2011
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: JNJ-38518168 / MTX
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Blood levels of methotrexate [ Time Frame: Up to approximately 7 weeks ] [ Designated as safety issue: No ]
    To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate


Secondary Outcome Measures:
  • Blood levels of JNJ-38518168 [ Time Frame: Up to approximately 7 weeks ] [ Designated as safety issue: No ]
    To assess the effect of methotrexate on the blood levels of JNJ-38518168

  • The number of participants with adverse events [ Time Frame: Up to approximately 7 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Time Frame: Up to approximately 7 weeks ] [ Designated as safety issue: No ]
    Blood and urine tests

  • Electrocardiograms [ Time Frame: Up to approximately 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: October 2011
Arms Assigned Interventions
Experimental: 001
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
Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose

Detailed Description:

This is an open-label (physician and participant will know the name of the assigned drug), multi-center, non-randomized, drug/drug interaction study of JNJ-38518168 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5-25 mg). The treatment phase will last 16 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 2 and again from Day 14 to Day 16. Participants completing treatment will have a follow-up visit between Days 22 and 25. Participants who discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the time of discontinuation or as soon as possible thereafter. The duration of participation in the study for an individual participant will be up to 7 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 2-15: Weekly MTX co-administered with two 50-mg capsules of JNJ-38518168, administered daily.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450982

Locations
United States, Alabama
Anniston, Alabama, United States
United States, Florida
Daytona Beach, Florida, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01450982     History of Changes
Other Study ID Numbers: CR018655, 38518168ARA1001
Study First Received: June 13, 2011
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Rheumatoid Arthritis
JNJ-38518168
Methotrexate

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014