Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments alx-0061, placebo, tocilizumab
Phase phase 2
Target IL-6
Sponsor Ablynx
Start date February 2015
End date September 2016
Trial size 228 participants
Trial identifier NCT02287922, 2014-003012-36, ALX0061-C202

Summary

The primary objective of this study is:

- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).

The secondary objectives of this study are:

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

- To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.

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
(Experimental)
Dose A of ALX-0061: every 4 weeks from Week 0 through Week 12 Placebo: every 2 weeks from Week 0 through Week 12
alx-0061
placebo
(Experimental)
Dose B of ALX-0061: every 2 weeks from Week 0 through Week 12 Placebo: every 2 weeks from Week 0 through Week 12
alx-0061
placebo
(Experimental)
- Dose C of ALX-0061: every 2 weeks from Week 0 through Week 12
alx-0061
(Active Comparator)
- Open-label TCZ according to the TCZ dosing regimen approved per region
tocilizumab

Primary Outcomes

Measure
Percentage of subjects with American College of Rheumatology 20 (ACR20)
time frame: Week 12

Secondary Outcomes

Measure
Proportion of subjects with ACR20, ACR50, and ACR70 response.
time frame: Week 12
Change from baseline in disease activity using Disease Activity Score 28 (DAS28), Simplified Disease Activity Index(SDAI) and Clinical Disease Activity Index (CDAI)
time frame: Week 12
Proportion of subjects with European League Against Rheumatism (EULAR) response
time frame: Week 12
Proportion of subjects in remission using DAS28(ESR), SDAI, CDAI and Boolean defined remission criteria
time frame: Week 12
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
time frame: Week 12
Change from baseline in Physical and mental component scores of Short Form Health Survey (SF-36).
time frame: Week 12
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue).
time frame: Week 12
Biomarker levels
time frame: From Day 0 till Week 24
anti-ALX-0061 antibodies (ADA)
time frame: From screening till week 24
ALX-0061 serum levels
time frame: From Day 0 till Week 12
Safety as measured by the incidence of adverse events and serious adverse events, clinical laboratory parameters and change from baseline in these parameters
time frame: From screening till week 24

Eligibility Criteria

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

Inclusion Criteria: - Diagnosis of RA (according to the 2010 EULAR/Americal College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III. - Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use. - Subjects must not have received MTX for at least 4 weeks before first administration of the study drug. - Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline - Others as defined in the protocol Exclusion Criteria: - Have been treated with DMARDs(Disease Modifying Antirheumatic Drugs)/systemic immunosuppressives during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug. - Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase [JAK]-inhibitors) 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 (including JAK inhibitors), 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 Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ablynx.