| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00950989 | Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate | PHASE2 | COMPLETED | 252 | — | — | Dec 30, 2009 | Feb 11, 2011 | Dec 21, 2021 | - | — |
| NCT00771030 | Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis | PHASE1 | COMPLETED | 40 | — | — | Oct 27, 2008 | May 25, 2010 | Nov 26, 2021 | - | — |
A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: * 50% improvement in 68 tender joint count; * 50% improvement in 66 swollen joint count; and * 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, including any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event was defined as an adverse event that was fatal; was life threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other significant medical hazard.
The investigator reviewed laboratory test results and determined whether an abnormal value in an individual study participant represented a change from prestudy values and determined if changes were clinically significant. The number of participants with clinically significant changes in lab values at any time during the study is reported.
Samples were tested in a validated immunoassay for the presence of anti-brodalumab binding antibodies. Samples found to be positive for binding antibodies were further tested using a validated cell-based bioassay to determine if the antibodies were able to neutralize the activity of brodalumab.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week). |
| Brodalumab 70 mg | EXPERIMENTAL | 70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week). |
| Brodalumab 140 mg | EXPERIMENTAL | 140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexateand folic acid supplementation (at least 5 mg per week). |
| Brodalumab 210 mg | PLACEBO_COMPARATOR | 210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week). |
| Placebo SC (Cohorts 1-3) | PLACEBO_COMPARATOR | Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses. |
| Placebo IV (Cohorts 5-6) | PLACEBO_COMPARATOR | Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses. |
| Brodalumab 50 mg SC (Cohort 1) | EXPERIMENTAL | Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| Brodalumab 140 mg SC (Cohort 2) | EXPERIMENTAL | Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| Brodalumab 210 mg SC (Cohort 3) | EXPERIMENTAL | Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses. |
| Brodalumab 420 mg IV (Cohort 5) | EXPERIMENTAL | Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
| Brodalumab 700 mg IV (Cohort 6) | EXPERIMENTAL | Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses. |
| Name | Type | Description |
|---|---|---|
| Brodalumab | DRUG | 3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10 |
| Placebo | DRUG | 3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10 |
| Methotrexate | DRUG | Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study. |
| folic acid | DIETARY_SUPPLEMENT | at least 5 mg per week |
Inclusion Criteria: * Active RA for least 6 months * Current RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and a...