Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02287922
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : January 4, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: ALX-0061 Biological: Placebo Biological: Tocilizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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
Biological: ALX-0061
Biological: Placebo
Experimental: ALX-0061 dose C
- Dose C of ALX-0061: every 2 weeks from Week 0 through Week 12
Biological: ALX-0061
Active Comparator: Tocilizumab
- Open-label TCZ according to the TCZ dosing regimen approved per region
Biological: Tocilizumab

Primary Outcome Measures :
  1. Percentage of subjects with American College of Rheumatology 20 (ACR20) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Proportion of subjects with ACR20, ACR50, and ACR70 response. [ Time Frame: Week 12 ]
  2. 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 ]
  3. Proportion of subjects with European League Against Rheumatism (EULAR) response [ Time Frame: Week 12 ]
  4. Proportion of subjects in remission using DAS28(ESR), SDAI, CDAI and Boolean defined remission criteria [ Time Frame: Week 12 ]
  5. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Week 12 ]
  6. Change from baseline in Physical and mental component scores of Short Form Health Survey (SF-36). [ Time Frame: Week 12 ]
  7. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). [ Time Frame: Week 12 ]
  8. Biomarker levels [ Time Frame: From Day 0 till Week 24 ]
  9. anti-ALX-0061 antibodies (ADA) [ Time Frame: From screening till week 24 ]
  10. ALX-0061 serum levels [ Time Frame: From Day 0 till Week 12 ]
  11. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02287922

  Show 83 Study Locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: Medical Monitor, MD Ablynx

Layout table for additonal information
Responsible Party: Ablynx Identifier: NCT02287922     History of Changes
Other Study ID Numbers: ALX0061-C202
2014-003012-36 ( EudraCT Number )
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases