Phase 2
Completed N=32
Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov NCT00669942 ↗Enrolled (actual)
32
Serious AEs
4.8%
Results posted
Mar 2015
Primary outcomePrimary: Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20) — 46; 27 percentage of participants
Summary
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20) |
46; 27 | — |
| PRIMARY Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 Participants |
0.09028; 0.08472; 0.1253; 0.1260 | — |
| PRIMARY PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 Participants |
8.772; 35.22; 70.95; 211.8 | — |
| PRIMARY PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 Participants |
141.3; 430.7; 1148; 4080; 132.7; 415.6 | — |
| PRIMARY PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 Participants |
7.043; 6.756; 6.506; 6.699 | — |
| PRIMARY PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 Participants |
0.2249; 0.2110; 0.2077; 0.1999 | — |
| PRIMARY PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 Participants |
23.21; 22.27; 23.47; 23.94 | — |
| PRIMARY Pharmacokinetics PK of AIN457: Tmax in Parts 2 and 3 Participants |
21.08; 21.08; 21.09 | — |
| PRIMARY Pharmacokinetics PK of AIN457: Cmax in Parts 2 and 3 Participants |
23.54; 97.78; 322.2 | — |
| PRIMARY Pharmacokinetics PK of AIN457: AUClast and AUCinf in Parts 2 and 3 Participants |
808.6; 2843; 8371; 746.4; 2704; 7815 | — |
| PRIMARY Pharmacokinetics PK of AIN457: Vz in Parts 2 and 3 Participants |
6.514; 6.062; 6.382 | — |
| PRIMARY Pharmacokinetics PK of AIN457: CL in Parts 2 and 3 Participants |
0.1834; 0.1775; 0.1994 | — |
| PRIMARY Pharmacokinetics PK of AIN457: T1/2 in Parts 2 and 3 Participants |
25.60; 23.89; 23.68 | — |
| SECONDARY Percentage of Parts 2 and 3 Participants Who Achieved ACR50 and ACR70 |
27; 15; 8; 8 | — |
| SECONDARY Disease Activity Score (DAS28) of Parts 2 and 3 Participants |
4.306; 4.598 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
- Post menopausal or surgically sterile female patients are allowed. Women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
- Patients must have a diagnosis of active rheumatoid arthritis of stages I, II or III (ACR 1987 revised classification for criteria for RA). Disease duration of at least 6 months prior to randomization is essential;
Exclusion Criteria
- Current treatment with anti-TNF-α or anti IL-1 therapy (or other biological therapy).
- Patients with congestive heart failure or poorly controlled diabetes mellitus (HbA1c value ≥10%).
- Presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or SLE that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
- History of renal trauma, glomerulonephritis or patient with one kidney.
- Pregnant or breastfeeding women will be excluded.
- A positive tuberculin skin test.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00669942). 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.