Rheumatoid ArthritisPhase 2NCT01911234
Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis
A Phase 2 study testing TNF-Kinoid in people with Rheumatoid Arthritis, run by Neovacs at 31 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TNF-Kinoid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 31 sitesin 10 countries
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
31 sites in 10 countries.
31 sites in 10 countries
Ukraine9 sites
Donetsk City Clinical Hospital #5
Donetsk
Gusak Institute of Urgent and Recovery Surgery of AMSU
Donetsk
Municipal Health Care Institution "Kharkiv City Clinical Hospital #8"
Kharkiv
Kyiv Out-patient hospital #2 of Shevchenko District
Kyiv
National medical academy of postgraduate education, Kiev regional clinical hospital
Kyiv
The Seventh Simferopol City Clinical Hospital
Simferopol
Municipal Institution "Central Hospital of Ordzhonikidze District"
Zaporizhzhya
State Institution "Departmental Clinical Hospital of Railway Station Zaporizhzhya-2" of the State Enterprise "Prydniprovska Zaliznytsya"
Zaporizhzhya
Zhitomir Regional Clinical Hospital named after O.F. Herbachevskogo
Zhytomyr
Georgia4 sites
"Acad. V. Tsitlanadze Scientific-Practical Center of Rheumatology" LLC
Tbilisi
"Medi Club Georgia" LLC
Tbilisi
Diagnostic services LTD
Tbilisi
Tbilisi Heart and Vascular Clinic LTD
Tbilisi
Russia4 sites
Municipal Clinical Hospital #4
Ivanovo
Regional Clinical Hospital for War Veterans
Kemerovo
City Clinical Hospital n.a.S.R.Mirotvortcev
Saratov
Clinical Hospital for Emergency Care n.a. N.V.Solovyev
Yaroslavl
Hungary3 sites
BKS Research Kft. Albert Schweitzer Kórhaz es Rendelőintezet-3. emelet
Hatvan
CRU Hungary Kft.
Szikszó
Csolnoky Ferenc Kórház
Veszprém
Lebanon3 sites
Ain Wazein Hospital
Aïn Ouzaïn
University Medical Center Rizk Hospital
Beirut
Hammoud Hospital Univeristy Medical Center
Sidon
Poland3 sites
Osteomedic Sc
Bialystok
NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
Krakow
Centrum Badań Klinicznych SC.
Poznan
Serbia2 sites
Institute of Rheumatology
Belgrade
Institute for treatment and rehabilitation "Niska Banja"-Nis
Niška Banja
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TNF-Kinoid, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-KinoidBiological
Also called ISA 51
IM administration
PlaceboOther
Also called ISA 51
IM administration
| Study group | Role | What they receive |
|---|---|---|
| TNF-Kinoid | Experimental | TNF Kinoid + ISA51 Receives: Biological: TNF-Kinoid |
| Placebo | Placebo comparator | Placebo + ISA51 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DAS28-CRP between Month 6 and baseline.
Measured: Month 6
Secondary outcomes (3)
Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline
Measured: Several timepoints during 24 weeks study period
Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
Measured: Several timepoints during 24 weeks study period
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)
Measured: Several timepoints during 24 weeks study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovacs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911234
- Sponsor's protocol ID
- TNF-K-006
- Other IDs
- 2013-001999-38
- Status last verified
- Mar 2019
- First submitted
- 23 Jul 2013
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01911234
- Acronym / sponsor ID
- TNF-K-006
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- NeovacsIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNF-Kinoid | Experimental | Biological: TNF-KinoidTNF Kinoid + ISA51 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo + ISA51 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF-KinoidAlso: ISA 51IM administration | Biological | TNF-Kinoid |
| PlaceboAlso: ISA 51IM administration | Other | Placebo |
Primary outcome
Change in DAS28-CRP between Month 6 and baseline.
Time frame: Month 6
3 secondary outcomes
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
Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines
Time frame: Several timepoints during 24 weeks study period
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNF-Kinoid in people with Rheumatoid Arthritis, run by Neovacs at 31 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Ukraine, Georgia, Russia, Hungary, Lebanon and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DAS28-CRP between Month 6 and baseline. (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.