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NCT Number: NCT01911234

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliniques Universitaires Saint Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNF-Kinoid

Biological

IM administration

Other names: ISA 51

Placebo

Other

IM administration

Other names: ISA 51

Primary outcomes

  1. Change in DAS28-CRP between Month 6 and baseline.

    Time frame: Month 6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Neovacs

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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