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Clinical Efficacy of TNF-Kinoid in Patients 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: NCT01911234
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : March 22, 2019
Information provided by (Responsible Party):

Brief Summary:

The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: TNF-Kinoid Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TNF-Kinoid
TNF Kinoid + ISA51
Biological: TNF-Kinoid
IM administration
Other Name: ISA 51

Placebo Comparator: Placebo
Placebo + ISA51
Other: Placebo
IM administration
Other Name: ISA 51

Primary Outcome Measures :
  1. Change in DAS28-CRP between Month 6 and baseline. [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline [ Time Frame: Several timepoints during 24 weeks study period ]
  2. Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines [ Time Frame: Several timepoints during 24 weeks study period ]
  3. Safety assessments will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory evaluations, and the recording of adverse events (AEs) [ Time Frame: Several timepoints during 24 weeks study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has had a diagnosis of RA according to the revised ACR criteria (Aletaha et al. 2010) for at least 6 months.
  • Has been treated with and tolerated MTX for at least 3 months prior to the first administration of study product, - Has at least four swollen joints/66 and/or four tender joints/68,
  • Has CRP ≥ 10 mg/L at screening.
  • Is positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptides (CCP) antibodies at screening.

Exclusion Criteria:

  • Has inflammatory rheumatic disease other than RA
  • Has been treated with non-biological DMARDs/systemic immunosuppressives
  • Has been treated with leflunomide within 12 weeks prior to first administration of study product.
  • Has received intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids
  • Has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another TNFα antagonist; or rituximab prior to the study.
  • Has been treated with any other biological DMARDs

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): NCT01911234

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Sponsors and Collaborators

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Responsible Party: Neovacs Identifier: NCT01911234     History of Changes
Other Study ID Numbers: TNF-K-006
2013-001999-38 ( EudraCT Number )
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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