Phase 2
Completed N=237
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
Source: ClinicalTrials.gov NCT00928512 ↗Enrolled (actual)
237
Serious AEs
6.0%
Results posted
Jul 2015
Primary outcomePrimary: Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks — 22; 20; 23; 18 Participants
Summary
This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks |
22; 20; 23; 18; 18 | — |
| SECONDARY Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16 |
7; 9; 9; 8; 3; 2 | — |
| SECONDARY Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16 |
7; 9; 9; 9; 3; 0 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP) |
-1.29; -1.35; -1.46; -1.13; -0.96 | — |
| SECONDARY Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2) |
3.42; 4.51; 3.48; 2.15; 2.47; -0.76 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16 |
2.80; 5.18; 3.89; 1.95; 1.64 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16 |
19.5; 18.6; 22.4; 18.9; 14.3; 43.9 | — |
| SECONDARY Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16 |
-5.66; -32.11; -77.62; 66.44; 85.63 | — |
| SECONDARY Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16 |
1444.67; 1098.81; 1178.88; 1342.50; 1406.79; 1478.53 | — |
| SECONDARY Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16 |
-5.4; -5.2; -6.0; -4.4; -4.6 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16 |
-1.48; -1.55; -1.65; -1.28; -1.14 | — |
| SECONDARY Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16 |
-6.3; -6.5; -6.3; -5.6; -5.0 | — |
| SECONDARY Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16 |
-9.0; -9.1; -11.6; -9.5; -9.1 | — |
| SECONDARY Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16 |
-10.1; -10.5; -18.4; -10.6; -9.9 | — |
| SECONDARY Change From Baseline in ACR Component: Physician's Global Assessment of Disease Activity at Week 16 |
-22.8; -26.7; -25.4; -18.1; -15.2 | — |
| SECONDARY Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16 |
-0.297; -0.256; -0.233; -0.202; -0.116 | — |
| SECONDARY Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP) |
-6.54; -7.76; -9.09; -4.08; 0.30 | — |
| SECONDARY Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16 |
-13.51; -15.06; -15.43; -9.86; -6.12 | — |
Eligibility Criteria
Inclusion Criteria
- Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (> or =7.5 mg/week - or = 6 out of 28 tender joints and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L OR ESR > or = 28 mm/1st hr
Exclusion Criteria
- RA patients functional status class IV classified according to the ACR 1991 revised criteria
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
- Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00928512). 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.