Study to assess safety and efficacy of anti-interleukin 6-receptor (IL6R) nanobody in rheumatoid arthritis (RA) patients (clinicaltrials.gov) - Apr 16, 2012 - P1/2, N=72; Recruiting -> Active, not recruiting
Enrollment closed • Immunology • Rheumatoid Arthritis
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This study is ongoing, but not recruiting participants.
First Received on January 21, 2011. Last Updated on April 16, 2012 History of Changes
Sponsor: Ablynx
Information provided by (Responsible Party): Ablynx
ClinicalTrials.gov Identifier: NCT01284569
Purpose
The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis (RA). Patients will receive different single or multiple doses of either placebo or ALX-0061.
Condition
Rheumatoid Arthritis
Intervention
Biological: ALX-0061
Biological: Placebo
Phase
Phase 1
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RA
Resource links provided by NLM:
MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
Further study details as provided by Ablynx:
Primary Outcome Measures:
Safety: number of treatment emergent adverse events (TEAEs) [ Time Frame: From first study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Pharmacokinetics (PK): serum concentration of ALX-0061 [ Time Frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part) ] [ Designated as safety issue: No ]
Biological efficacy: pharmacodynamic (PD) markers [ Time Frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part) ] [ Designated as safety issue: No ]
C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), fibrinogen, interleukin 6 (IL6), soluble IL6 receptor (sIL6R), tumour necrosis factor alpha (TNFalpha), interleukin 1 beta (IL1beta), interferon gamma (IFNgamma)
Disease activity: RA-related assessments [ Time Frame: From first day prior to study drug administration until last follow-up visit (i.e. 90 days after dosing for single dose part, 210 days after first dose for multiple dose part) ] [ Designated as safety issue: No ]
ACR response, DAS28 score, EULAR response
Estimated Enrollment: 72
Study Start Date: March 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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