Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: ACZ885

• Registration Number: NCT00619905
• Lead Sponsor: Novartis

Brief Summary

This study assessed the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2008-02
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-08
• Last Update Submitted: 2008-02-08
• Study First Posted: 2008-02-21
• Last Update Posted: 2008-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Male and female patients aged 18.5 - 65/75 years (depending on the dose group).
• Diagnosis of rheumatoid arthritis (ACR 1987 revised classification for criteria for RA) with a disease duration of at least 6 months prior to randomization.
• Active disease at screening and baseline evaluation (same evaluator) ) with more than 6 tender and 6 swollen joints of 28 examined (including any effused joint) and either a) Westergren erythrocyte sedimentation (ESR) ≥ 28 mm/hour, or b) CRP ≥ 6 mg/L.
• Patients should have failed at least 1 DMARD in the past, but should not be deemed "refractory to all therapies"
• Patients should have a current treatment regimen of ≥ 15 mg methotrexate/week and with the current dose stable for approximately 3 months.
• Patients were required to have an otherwise stable RA therapeutic regimen, consisting of either a stable dose of NSAIDs and/or a stable dose of oral corticosteroids (prednisone or equivalent < 10 mg daily) for at least 4 weeks prior to randomization.

Exclusion Criteria

• Previous treatment with anti-TNF-α antibody therapy (or other biological therapy) within appropriate timeframe (considering the half life of the compound)
• Patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute RA flare (not being part of a regular therapeutic regimen) within four weeks prior to randomization OR require narcotic analgesics other than those accepted by the investigator for analgesia (e.g., codeine, tramadol, dextropropoxyphene)

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ACZ885	-
1	ACZ885	-

Primary Outcome Measures

Name	Time	Method
Adverse events and infections occurrence throughout the study.	throughout the study
Presence of anti-ACZ885 antibodies in serum at baseline, Days 43, 71 and end of study (Day 113).	throughout the study

Secondary Outcome Measures

Name	Time	Method
ACR response criteria [including joint counts, patient/investigator disease activity and pain assessment, acute phase reactants (ESR and CRP) and a Health Assessment Questionnaire (HAQ)] .	throughout the study
Disease Activity Score (DAS) at baseline and Days 43 and 113.	throughout the study
Quantification of IL-1B, IL-6, and C-reactive protein (CRP), matrix metalloproteinases (MMPs) 1 and 3, and c-telopeptide of Type I collagen (Crosslaps), at Week 7 versus baseline.	throughout the study
Serum concentrations of ACZ885 at each visit.	throughout the study

Trial Locations

Locations (1)

Novartis Investigator Site; 🇨🇭 Geneva, Switzerland