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A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02309359
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ablynx

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 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, 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
Study Start Date : January 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group 1: Placebo
Placebo, at week 0 and every 2 weeks thereafter up to and including week 22
Other: Placebo
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Experimental: Group 2: ALX-0061 Dose A + Placebo

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.

Biological: ALX-0061
Other: Placebo
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Experimental: Group 3: ALX-0061 Dose B + Placebo

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.

Biological: ALX-0061
Other: Placebo
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Experimental: Group 4: ALX-0061 Dose B + Placebo

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.

Biological: ALX-0061
Other: Placebo
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).

Experimental: Group 5: ALX-0061 Dose C
ALX-0061 Dose C at Week 0 and every 2 weeks thereafter up to and including Week 22.
Biological: ALX-0061
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).




Primary Outcome Measures :
  1. Proportion of subjects achieving an ACR20 response. [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Proportion of subjects with ACR20, ACR50, and ACR70 response. [ Time Frame: Week 24 ]
  2. Change from baseline in disease activity using DAS28, SDAI and CDAI. [ Time Frame: Week 24 ]
  3. Proportion of subjects with EULAR response. [ Time Frame: Week 24 ]
  4. Proportion of subjects in remission using DAS28(ESR), SDAI, CDAI and Boolean defined remission criteria. [ Time Frame: Week 24 ]
  5. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI). [ Time Frame: Week 24 ]
  6. Change from baseline in physical and mental component scores of Short Form Health Survey (SF-36). [ Time Frame: Week 24 ]
  7. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). [ Time Frame: Week 24 ]
  8. Pharmacodynamics as measured by the concentration of biomarker levels in plasma and serum. [ Time Frame: 34 weeks ]
  9. Immunogenicity as measured by the concentration of anti-ALX-0061 antibodies in serum. [ Time Frame: 34 weeks ]
  10. Pharmacokinetics as measured by the concentration of ALX-0061 in serum. [ Time Frame: 24 weeks ]
  11. The incidence of Adverse Events and Serious Adverse Events. The clinical laboratory parameters and change from baseline in these parameters. [ Time Frame: 34 weeks ]


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02309359


  Show 94 Study Locations
Sponsors and Collaborators
Ablynx
Investigators
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Study Director: Ablynx Clinical Department Ablynx

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Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02309359     History of Changes
Other Study ID Numbers: ALX0061-C201
2014-003033-26 ( EudraCT Number )
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors