Phase 2
Completed N=252
Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT00950989 ↗Enrolled (actual)
252
Serious AEs
2.8%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 — 12.7; 15.9; 15.9; 9.5 percentage of participants — p=0.598
Summary
Study in participants with RA who have an inadequate response to methotrexate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 |
12.7; 15.9; 15.9; 9.5 | 0.598 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 |
42.9; 39.7; 36.5; 46.0 | 0.728 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 |
3.2; 3.2; 3.2; 0.0 | 0.984 |
| SECONDARY Disease Activity Score 28 (DAS28) at Week 12 |
5.0; 4.9; 5.1; 5.1 | 0.459 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation |
32; 32; 40; 32; 2; 1 | — |
| SECONDARY Pharmacokinetics (PK) of Brodalumab: Maximum Observed Concentration (Cmax) |
3.02; 7.85; 17.9 | — |
| SECONDARY PK of Brodalumab: Time to Maximum Observed Concentration (Tmax) |
1.94; 2.00; 1.96 | — |
| SECONDARY PK of Brodalumab: Area Under the Curve During the Dosing Interval (AUCtau) |
18.1; 73.3; 199 | — |
Eligibility Criteria
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 at least 1 of the following at screening: Erythrocyte sedimentation rate ≥ 28 mm or C-reactive protein > 15 mg/L
- At least 1 of the following at screening: Rheumatoid factor positive or Anti-cyclic citrullinated peptide antibody positive
- Currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1.
Exclusion Criteria
- Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
- Class IV RA
- Felty's syndrome
- Presence of serious infection
- Significant concurrent medical conditions
- Pregnant or breast feeding
- Significant Laboratory abnormalities
- Any disease-modifying anti-rheumatic drug (DMARD) other than methotrexate within 28 days
- Leflunomide or live vaccines within 3 months
- Previous use of any experimental or commercially available biologic DMARD
Data sourced from ClinicalTrials.gov (NCT00950989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.