Status:
COMPLETED
Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis
Lead Sponsor:
Neovacs
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01911234
Start Date
September 1 2013
End Date
September 1 2014
Last Update
March 22 2019
Active Locations (31)
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1
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
2
"Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
Tbilisi, Georgia
3
"Medi Club Georgia" LLC
Tbilisi, Georgia
4
Diagnostic services LTD
Tbilisi, Georgia