Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Neovacs
ClinicalTrials.gov Identifier:
NCT01911234
First received: July 23, 2013
Last updated: April 11, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Biological: TNF-Kinoid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Neovacs:

Primary Outcome Measures:
  • Change in DAS28-CRP between Month 6 and baseline. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines [ Time Frame: Several timepoints during 24 weeks study period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TNF-Kinoid
TNF Kinoid + ISA51
Biological: TNF-Kinoid
Placebo Comparator: Placebo
Placebo + ISA51

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911234

  Show 31 Study Locations
Sponsors and Collaborators
Neovacs
  More Information

No publications provided

Responsible Party: Neovacs
ClinicalTrials.gov Identifier: NCT01911234     History of Changes
Other Study ID Numbers: TNF-K-006, 2013-001999-38
Study First Received: July 23, 2013
Last Updated: April 11, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
Georgia: Ministry of Health
Hungary: National Institute of Pharmacy
Lebanon: Institutional Review Board
Macedonia: Ministry of Health
Moldova: Medicines Agency
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Serbia: Medicines and Medical Devices Agency
Ukraine: Ministry of Health

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

ClinicalTrials.gov processed this record on October 21, 2014