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Also known as CNTO 6785
CNTO 6785/kg · 2 trials · 2 indications
FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
American College of Rheumatology (ACR) 20 response is a \>=20% improvement in rheumatoid arthritis (RA) symptoms.
| Arm | Type | Description |
|---|---|---|
| CNTO 6785 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Placebo/CNTO 6785 200 mg+Methotrexate (MTX) | PLACEBO_COMPARATOR | - |
| CNTO 6785 200 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 100 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 50 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 15 mg+MTX | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CNTO 6785 | DRUG | CNTO 6785 (6 mg/kg) will be administered by intravenous (into a vein) infusion on Weeks 0, 2, 4, 8 and 12. Participants who weigh more than 100 kg will receive a dose of 600 mg of CNTO 6785. |
| Placebo | DRUG | Sterile, 5 percent dextrose will be used as the placebo in this study. Placebo will be administered by intravenous infusion on Weeks 0, 2, 4, 8 and 12. |
| CNTO 6785 200 mg | DRUG | CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28 |
| CNTO 6785 100 mg | DRUG | CNTO 6785 100 mg SC every 4 weeks through Week 28 |
| CNTO 6785 50 mg | DRUG | CNTO 6785 50 mg SC every 4 weeks through Week 28 |
| CNTO 6785 15 mg | DRUG | CNTO 6785 15 mg SC every 4 weeks through Week 28 |
| Methotrexate (MTX) | DRUG | MTX at the same stable dose through Week 32, that participants were receiving prior to screening. |
Inclusion criteria: * Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) (Grade II or Grade III according to the GOLD Guidelines) with chronic bronchitis (sputum production on most days for at least 12 weeks per year for at least 2 successive years) at screening * Persistent COPD sympt...
CNTO 6785 was studied for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) and for active rheumatoid arthritis in patients who continued to have disease activity despite methotrexate therapy. Both programs were Phase 2 clinical studies and the drug is not approved for any indication.
CNTO 6785 was developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 2 studies of the compound in COPD and rheumatoid arthritis.
CNTO 6785 is in Phase 2 development. Two Phase 2 trials have been completed, one in chronic obstructive pulmonary disease and one in rheumatoid arthritis, and no active trials of the drug are currently listed. It is an investigational agent and has not been approved by the FDA.
CNTO 6785 was evaluated in two completed Phase 2 trials. NCT01966549 tested it in 187 patients with moderate to severe chronic obstructive pulmonary disease across Europe and Asia. NCT01909427 tested it in 257 patients with active rheumatoid arthritis despite methotrexate therapy. Both were randomized, double-blind and placebo-controlled.
The CNTO 6785 clinical program enrolled 257 participants in the rheumatoid arthritis Phase 2 trial, NCT01909427, and 187 participants in the COPD Phase 2 trial, NCT01966549. Both studies were randomized, double-blind and placebo-controlled, and both have been completed.