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JNJ-40346527 · 2 trials · 2 indications
The DAS28 is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and an overall assessment of disease activity.
| Arm | Type | Description |
|---|---|---|
| JNJ-40346527 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 001 | EXPERIMENTAL | JNJ-40346527/Placebo Single oral dose of JNJ-40346527 (either 10 50 150 300 600 or 1000mg) or Placebo |
| 002 | EXPERIMENTAL | JNJ-40346527/Placebo JNJ-40346527 once daily oral dose for 14 days (either 50 150 300 500 or 750mg) or Placebo |
| 003 | EXPERIMENTAL | JNJ-40346527 JNJ-40346527 150mg one dose either fasting (or with food) then after 7 days off treatment JNJ-40346527 150mg either with food (or fasting) |
| Name | Type | Description |
|---|---|---|
| JNJ-40346527 | DRUG | Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily. |
| Placebo | DRUG | Form=capsule; route=oral use; twice daily. |
| JNJ-40346527/Placebo | DRUG | Single oral dose of JNJ-40346527 (either 10, 50, 150, 300, 600, or 1000mg) or Placebo |
Inclusion Criteria: * Diagnosis of rheumatoid arthritis (RA) for at least 6 months prior to screening * Have been positive for, or are positive at screening for, either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum * Have active RA with at least 6 swollen ...
JNJ-40346527 is an investigational small molecule developed by Johnson & Johnson for immunology indications. It has been studied in rheumatoid arthritis, specifically in patients with active disease despite disease-modifying antirheumatic drug therapy. It is not an approved medicine and remains in clinical development.
JNJ-40346527 was studied as a treatment for active rheumatoid arthritis in adults who continued to have active disease despite disease-modifying antirheumatic drug therapy. The Phase 2 trial enrolled 96 patients across Argentina, Bulgaria, Chile, Czechia, Hungary, Poland, Russia, Singapore, South Korea, and Ukraine. No approved use exists for this investigational agent.
Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ, is the developer of JNJ-40346527. The company sponsored the clinical program for the compound, including the Phase 1 healthy volunteer study and the Phase 2 rheumatoid arthritis study.
JNJ-40346527 has completed Phase 2 testing in rheumatoid arthritis and is not FDA approved. The Phase 2 trial, NCT01597739, was a randomized, double-blind, placebo-controlled study that has been completed. A separate Phase 1 study in healthy volunteers, NCT01054014, is also completed.
Two completed trials are registered for JNJ-40346527. NCT01597739 was a Phase 2 randomized, double-blind, placebo-controlled study in 96 adults with active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy. NCT01054014 was a Phase 1 single and multiple dose study of safety in 120 healthy volunteers in Belgium.
JNJ-40346527 is a small molecule immunology agent developed for rheumatoid arthritis. It was evaluated in a randomized, double-blind, placebo-controlled Phase 2 trial in patients with active disease despite disease-modifying antirheumatic drug therapy, and in a Phase 1 safety study in healthy volunteers.