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| ID | Type | Description | Link |
|---|---|---|---|
| 39758979ARA1001 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | |
| 2011-001227-20 | EudraCT Number |
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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.
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-39758979 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5 - 25 mg). The treatment phase will last 17 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 3 and again from Day 13 to Day 17. 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 length of participation in the study for an individual participant may be up to 9 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 3-15: Weekly MTX co-administered with three 100-mg, enteric-coated tablets of JNJ-39758979, administered daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-39758979 / MTX | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of methotrexate | To assess the effect of multiple doses of JNJ-39758979 on blood levels of methotrexate | Up to approximately 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of JNJ 39758979 | To assess the effect of MTX on the blood levels of JNJ 39758979 | Up to approximately 7 weeks |
| The number of participants with adverse events | Up to approximately 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J&J Pharmaceutical Research & Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | United States | ||||
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| Clinical laboratory tests | Blood and urine tests | Up to approximately 7 weeks |
| Electrocardiograms | Up to approximately 7 weeks |
| Duncansville |
| Pennsylvania |
| United States |
| Dallas | Texas | United States |
| Berlin | Germany |
| Munich | Germany |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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