Phase 2
Completed N=42
Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
Source: ClinicalTrials.gov NCT00809614 ↗Enrolled (actual)
42
Serious AEs
11.9%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of ACR Responders Per Treatment at Week 6 — 39; 23; 17; 8 Percentage of ACR responders
Summary
This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of ACR Responders Per Treatment at Week 6 |
39; 23; 17; 8; 9; 0 | — |
| PRIMARY Percentage of PsARC Responders Per Treatment at Week 6 |
43; 38 | — |
| SECONDARY Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria |
17; 8; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved PsARC Response |
27; 23; 33; 15; 43; 38 | — |
| SECONDARY Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment |
3.0; 3.4; 2.6; 2.7; 2.9; 2.8 | — |
| SECONDARY Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment |
3.5; 2.4; 1.0; 3.10; 0.71; 3.3 | — |
| SECONDARY SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment |
4.42; 6.08; 3.65; 4.27; 4.10; 5.27 | — |
| SECONDARY Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment |
2.74; 1.56; 2.92; 2.14; 2.52; 0.73 | — |
| SECONDARY Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment |
4.84; 4.76; 3.94; 4.20; 3.62; 4.36 | — |
| SECONDARY Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) |
21.0 | — |
| SECONDARY Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration |
0.161 | — |
| SECONDARY Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2) |
29.8 | — |
| SECONDARY Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) |
424 | — |
| SECONDARY PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) |
12300; 12600 | — |
| SECONDARY Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) |
6.81 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of psoriatic arthritis
Exclusion Criteria
- Patients with arthritis or ankylosing spondyitis
- Drug-induced psoriasis
- Male or female patients who plan to conceive during the time course of the study, or for 6 months after the administration of the second dose.
- Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
- Previous use of immunosuppressive agents eg cyclosporine, without the necessary wash-out period
- History of severe allergy to food or drugs
- Positive TB test. Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00809614). 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.