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A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02287922
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ablynx

Tracking Information
First Submitted Date  ICMJE November 5, 2014
First Posted Date  ICMJE November 11, 2014
Last Update Posted Date January 4, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
Percentage of subjects with American College of Rheumatology 20 (ACR20) [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02287922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Biological: ALX-0061
  • Biological: Placebo
  • Biological: Tocilizumab
Study Arms  ICMJE
  • Experimental: ALX-0061 dose A + Placebo
    • Dose A of ALX-0061: every 4 weeks from Week 0 through Week 12
    • Placebo: every 2 weeks from Week 0 through Week 12
    Interventions:
    • Biological: ALX-0061
    • Biological: Placebo
  • Experimental: ALX-0061 dose B + Placebo
    • Dose B of ALX-0061: every 2 weeks from Week 0 through Week 12
    • Placebo: every 2 weeks from Week 0 through Week 12
    Interventions:
    • Biological: ALX-0061
    • Biological: Placebo
  • Experimental: ALX-0061 dose C
    - Dose C of ALX-0061: every 2 weeks from Week 0 through Week 12
    Intervention: Biological: ALX-0061
  • Active Comparator: Tocilizumab
    - Open-label TCZ according to the TCZ dosing regimen approved per region
    Intervention: Biological: Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2017)
251
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2014)
228
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Czechia,   Georgia,   Germany,   Hungary,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Moldova, Republic of,   Poland,   Romania,   Serbia,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02287922
Other Study ID Numbers  ICMJE ALX0061-C202
2014-003012-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ablynx
Study Sponsor  ICMJE Ablynx
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor, MD Ablynx
PRS Account Ablynx
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP