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Clinical Trials/NCT02287922
NCT02287922
Completed
Phase 2

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

Ablynx, a Sanofi company6 sites in 4 countries251 target enrollmentStarted: March 2015Last updated:
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ConditionsRheumatoid Arthritis

Overview

Phase
Phase 2
Status
Completed
Sponsor
Ablynx, a Sanofi company
Enrollment
251
Locations
6
Primary Endpoint
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of RA (according to the 2010 EULAR/American 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 immunosuppressive drugs 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.

Outcomes

Primary Outcomes

Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12

Time Frame: Week 12

ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.

Secondary Outcomes

  • Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12(Week 12)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12(From baseline until Week 12)
  • Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)(From baseline until Week 12)
  • Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12(From baseline until Week 12)
  • Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12(Week 12)
  • Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12(Week 12)
  • Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event(From baseline until Week 12)
  • Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12(Week 12)
  • Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12(Week 12)
  • Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12(Week 12)
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12(From baseline until Week 12)
  • Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12(From baseline until week 12)
  • Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12(Week 12)
  • Number and Percentage of Subjects in Remission Using SDAI at Week 12(Week 12)
  • Number and Percentage of Subjects in Remission Using CDAI at Week 12(Week 12)
  • Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12(Week 12)
  • Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response(From first study drug intake up to and including follow-up (FU), i.e., maximum of 22 weeks (10 weeks of treatment + 12 weeks of FU))
  • Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity(From baseline until Week 12)
  • Number of Treatment-emergent Adverse Event by Severity(From baseline until Week 12)
  • Number of Treatment-related Treatment-emergent Adverse Event(From baseline until Week 12)

Investigators

Sponsor
Ablynx, a Sanofi company
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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