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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

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

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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 ]


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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 (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 ClinicalTrials.gov identifier (NCT number): NCT02287922


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Locations
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United States, Alabama
Investigator Site
Birmingham, Alabama, United States, 35216
United States, California
Investigator Site
Hemet, California, United States, 92543
Investigator Site
La Palma, California, United States, 90712
Investigator site
Los Angeles, California, United States, 90017
Investigator Site
Los Angeles, California, United States, 90036
Investigator site
Ventura, California, United States, 93003
United States, Florida
Investigator site
Hialeah, Florida, United States, 33016
Investigator Site
Homestead, Florida, United States, 33030
Investigator Site
Orlando, Florida, United States, 32804
United States, Georgia
Investigator Site
Stockbridge, Georgia, United States, 30281
United States, Kansas
Investigator site
Overland Park, Kansas, United States, 66209
United States, Massachusetts
Investigator Site
Worcester, Massachusetts, United States, 01605
United States, New Mexico
Investigator Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Investigator Site
New York, New York, United States, 10018
United States, South Carolina
Investigator Site
Charleston, South Carolina, United States, 29406
United States, Tennessee
Investigator Site
Memphis, Tennessee, United States, 38119
United States, Texas
Investigator Site
Mesquite, Texas, United States, 75150
Belgium
Investigator Site
Brussels, Belgium, 1200
Investigator Site
Ghent, Belgium, 9000
Investigator Site
Liège, Belgium, 4000
Bulgaria
Investigator Site
Burgas, Bulgaria
Investigator Site
Pleven, Bulgaria
Investigator Site 1
Plovdiv, Bulgaria
Investigator Site 2
Plovdiv, Bulgaria
Investigator Site 1
Ruse, Bulgaria
Investigator Site 2
Ruse, Bulgaria
Investigator Site
Sofia, Bulgaria
Czechia
Investigator Site
Brno, Czechia, 602000
Investigator Site
Olomouc, Czechia
Investigator Site
Ostrava, Czechia, 70300
Investigator Site 1
Prague, Czechia
Investigator Site 2
Prague, Czechia
Investigator Site
Zlin, Czechia
Georgia
Investigator Site
Tbilisi, Georgia, 0102
Investigator Site 1
Tbilisi, Georgia, 0159
Investigator Site 2
Tbilisi, Georgia, 0159
Investigator Site
Tbilisi, Georgia, 0160
Investigator Site
Tbilisi, Georgia, 0179
Germany
Investigator Site
Berlin, Germany
Investigator Site
Frankfurt, Germany
Investigator Site
Hamburg, Germany
Hungary
Investigator Site
Baja, Hungary, 6500
Investigator Site
Budapest, Hungary
Investigator Site
Esztergom, Hungary
Investigator site
Gyula, Hungary, 5700
Investigator Site
Szikszo, Hungary, 3800
Investigator Site
Szombathely, Hungary, 9700
Investigator Site
Székesfehérvar, Hungary, 8000
Investigator Site
Veszprém, Hungary, 8200
Macedonia, The Former Yugoslav Republic of
Investigator Site 1
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Investigator Site 2
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Investigator Site
Culiacan, Mexico
Investigator Site
Leon, Mexico
Investigator Site
Mexico City 1, Mexico
Investigator Site 1
Mexico City, Mexico
Investigator Site 2
Mexico City, Mexico
Investigator Site 1
Monterrey, Mexico
Investigator Site 2
Monterrey, Mexico
Moldova, Republic of
Investigator Site
Chisinau, Moldova, Republic of, 2025
Investigator Site
Chisinau, Moldova, Republic of
Poland
Investigator Site
Bydgoszcz, Poland
Investigator Site 2
Elblag, Poland, 82300
Investigator Site
Elblag, Poland
Investigator Site
Gdynia, Poland
Investigator Site
Grodzisk Mazowiecki, Poland, 05825
Investigator Site
Lublin, Poland, 20582
Investigator SIte
Poznan, Poland, 60773
Investigator Site
Sochaczew, Poland, 96500
Investigator Site
Torun, Poland, 87100
Investigator Site
Warszawa, Poland, 02653
Romania
Investigator Site
Bucharest, Romania
Investigator Site
Oradea, Romania
Investigator Site
Timisoara, Romania
Serbia
Investigator Site 1
Belgrade, Serbia
Investigator Site 2
Belgrade, Serbia
Investigator Site 3
Belgrade, Serbia
Investigator Site
Niska Banja, Serbia
Spain
Investigator Site
Cordoba, Spain
Investigator Site
Madrid, Spain, 28007
Investigator Site
Santander, Spain, 39300
Investigator Site 2
Santander, Spain
Investigator Site 1
Santiago de Compostela, Spain
Investigator Site 2
Santiago de Compostela, Spain
Sponsors and Collaborators
Ablynx
Investigators
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Study Director: Medical Monitor, MD Ablynx

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Responsible Party: Ablynx
ClinicalTrials.gov 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:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases