Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments alx-0061, placebo
Phase phase 2
Target IL-6
Sponsor Ablynx
Start date January 2015
End date October 2016
Trial size 345 participants
Trial identifier NCT02309359, 2014-003033-26, ALX0061-C201

Summary

The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active RA despite MTX therapy, compared with placebo.

To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo, at week 0 and every 2 weeks thereafter up to and including week 22
placebo
(Experimental)
ALX-0061 Dose A at week 0 and every 4 weeks thereafter up to and including Week 20. Placebo at week 0 and every 2 weeks thereafter up to and including week 22.
alx-0061
placebo
(Experimental)
ALX-0061 Dose B at week 0 and every 4 weeks thereafter up to and including Week 20. Placebo at week 0 and every 2 weeks thereafter up to and including week 22.
alx-0061
placebo
(Experimental)
ALX-0061 Dose B at Week 0 and every 2 weeks thereafter up to and including Week 22. Placebo at week 0 and every 2 weeks thereafter up to and including week 22.
alx-0061
placebo
(Experimental)
ALX-0061 Dose C at Week 0 and every 2 weeks thereafter up to and including Week 22.
alx-0061

Primary Outcomes

Measure
Proportion of subjects achieving an ACR20 response.
time frame: Week 12

Secondary Outcomes

Measure
Proportion of subjects with ACR20, ACR50, and ACR70 response.
time frame: Week 24
Change from baseline in disease activity using DAS28, SDAI and CDAI.
time frame: Week 24
Proportion of subjects with EULAR response.
time frame: Week 24
Proportion of subjects in remission using DAS28(ESR), SDAI, CDAI and Boolean defined remission criteria.
time frame: Week 24
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI).
time frame: Week 24
Change from baseline in physical and mental component scores of Short Form Health Survey (SF-36).
time frame: Week 24
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue).
time frame: Week 24
Pharmacodynamics as measured by the concentration of biomarker levels in plasma and serum.
time frame: 34 weeks
Immunogenicity as measured by the concentration of anti-ALX-0061 antibodies in serum.
time frame: 34 weeks
Pharmacokinetics as measured by the concentration of ALX-0061 in serum.
time frame: 24 weeks
The incidence of Adverse Events and Serious Adverse Events. The clinical laboratory parameters and change from baseline in these parameters.
time frame: 34 weeks

Eligibility Criteria

Male or female participants from 18 years up to 74 years old.

Inclusion Criteria: - Diagnosis of RA for at least 6 months prior to screening, and ACR functional class I-III - Subjects treated with and tolerating MTX - Active RA - Others as defined in the protocol Exclusion Criteria: - Have been treated with DMARDs/systemic immunosuppressives other than MTX. - Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening. - Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs, for RA. - Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time. - Others as defined in the protocol

Additional Information

Official title A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Ablynx.