Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)


Tracking Information

tart Date  ICMJEJuly 2009
Estimated Primary Completion DateApril 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2009)		efficacy (ACR20 criteria) at various doses of AIN457 compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX) [ Time Frame: week 16 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00928512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: June 25, 2009)
  • To assess the speed of onset of response based on ACR20 and ACR50 [ Time Frame: at 2, 4 and 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of AIN457 by assessing the response to treatment (ACR 50 and 70 criteria, DAS 28) compared to placebo [ Time Frame: at Week 16 ] [ Designated as safety issue: No ]
  • To assess the effect of AIN457 on ACR components, including markers of inflammation (hsCRP and ESR) compared to placebo [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • To assess the immunogenicity, PK/PD of AIN457 and efficacy of AIN457 on quality of life and fatigue [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • To evaluate the overall safety and tolerability of AIN457 [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEEfficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
Official Title  ICMJEA 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous AIN457 Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate
Brief 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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition  ICMJERheumatoid Arthritis
Intervention  ICMJE
  • Biological: AIN457
  • Biological: Placebo
Study Arms / Comparison Groups
  • AIN457 1: Experimental
    Intervention: Biological: AIN457
  • AIN457 2: Experimental
    Intervention: Biological: AIN457
  • AIN457 3: Experimental
    Intervention: Biological: AIN457
  • AIN457 4: Experimental
    Intervention: Biological: AIN457
  • Placebo: Placebo Comparator
    Intervention: Biological: Placebo

Recruitment Information

Estimated Enrollment  ICMJE200
Completion Date 
Estimated Primary Completion DateApril 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 = 25 mg/week) for at least 4 weeks
  • At Baseline: Disease activity criteria defined by > 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

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals862-778-8300
Location Countries  ICMJEUnited States,   Belgium,   Czech Republic,   Germany,   Hungary,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Taiwan

Administrative Information

NCT ID  ICMJENCT00928512
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECAIN457F2201, EudraCT number: 2009-011000-34
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByNovartis