Rheumatoid ArthritisPhase 4NCT02132234
Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
A Phase 4 study testing Etanercept, Adalimumab and Certolizumab in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Jagiellonian University at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- What is being tested?
- Etanercept, Adalimumab and Certolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2013to Jul 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients suffering from rheumatoid arthritis:
- rheumatoid arthritis diagnosed based on The American Rheumatism Association Criteria from 1987
- ineffective treatment with 2 disease-modifying antirheumatic drugs (DMARDs) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment)
- high disease activity - Disease Activity Score 28 (DAS 28) > 5,1 measured twice, with a 1-month interval
- for patients with mainly lower limbs affected with DAS 28 > 3,7
- For patients suffering from Ankylosing Spondylitis:
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- Ankylosing Spondylitis diagnosed based on Modified New York Criteria
- ineffective treatment with 2 non-steroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months
- high disease activity -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4 measured twice, with a 12-week interval
- spinal pain > 4cm on 10cm Visual Analogue Scale (VAS) measured twice, with a 12-week interval
- general disease activity assessment > 5 (0-10 scale) performed after the 2nd VAS and BASDAI assessment
- For patients suffering from Psoriatic Arthritis:
- Psoriatic arthritis diagnosed based on the Bennett or Classification Criteria for Psoriatic Arthritis (CASPAR Criteria)
- If peripheral joints are affected:
- active disease assessed twice, with a 4-week interval on stable treatment, after 2 DMARDs treatment for at least 4 months
- Criteria of active disease (all have to be met):
- At least 5 out of 66 joints swollen - assessed twice, with a 4-week interval
- At least 5 out of 68 joints tender - assessed twice, with a 4-week interval
- general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by patient
- general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by physician
- general disease activity assessment > 5 (0-10 scale) performed after 2nd assessment of number of tender and swollen joints
- If axial joints are affected:
- Sacroiliac joints affected according to the New York Criteria of Ankylosing Spondylitis
- Active and severe disease assessed twice, with a 12-week interval, stable treatment, ineffective treatment with 2 nonsteroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months each
- Criteria of active disease (all must be present):
- BASDAI > 4 measured twice, with a 12-week interval
- spinal pain > 4cm on 10 cm in the VAS measured twice, with a 12-week interval
- general disease activity assessment > 5 (0-10 scale) Patients can take steroid in stable dose within one month - maximal dose 10mg/day of prednisone.
Who cannot join
- non-consenting patient
- pregnancy
- breast-feeding
- allergy for the drug or any component
- cardiac insufficiency (NYHA III or IV)
- active infection
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- infection within the last 3 months: hepatitis, pneumonia, pyelonephritis
- opportunistic infection within the last 2 months: active infection of cytomegalovirus, Pneumocystis carinii
- joint infection within the last 12 months
- endoprosthesis infection within the last 12 months or any time if the joint was not replaced
- exacerbation of lung-, kidney-, liver- or heart insufficiency during treatment
- demyelinating disease or its symptoms
- pancytopenia or aplastic anemia
- pre-cancer stage
- neoplasm within the last 5 years including solid tumors and neoplasm of haematopoietic or lymphatic system with risk of recurrence or progression
- active alcoholic disease
- chronic liver disease
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński
Krakow, Skarbowa 4, 31-121
Bogdan Batko, MD, PhD, 48126876261
Agata Schramm, MD, 48126876210
About this study
The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
- Being tested
- Etanercept, Adalimumab, Certolizumab, Infliximab
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
biological treatment according to rheumatologic indication
AdalimumabDrug
biological treatment according to rheumatologic indication
CertolizumabDrug
biological treatment according to rheumatologic indication
InfliximabDrug
biological treatment according to rheumatologic indication
| Study group | Role | What they receive |
|---|---|---|
| Biological treatment | Experimental | Patients with high disease activity receiving biological treatment according to rheumatologic indication:
* etanercept 50 mg s.c. every week
* adalimumab 40 mg s.c. every 2 weeks
* certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks
* infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks Receives: Drug: Etanercept; Drug: Adalimumab; Drug: Certolizumab; Drug: Infliximab |
| control group | Placebo comparator | Patients with high disease activity receiving other than biological treatment and receiving placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood pressure
Ambulatory Blood Pressure Monitoring (ABPM)
Measured: prior to receiving anti-TNF-α treatment, 12 weeks
Secondary outcomes (1)
Change from baseline in endothelial function
Flow Mediated Dilatation / Endo Pat
Measured: prior to receiving anti-TNF-α treatment, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJun 2013
- Primary completionJul 2014 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland
- Responsible party
- Principal investigator, Tomasz Guzik, Jagiellonian University
- Investigators
- Tomasz Guzik, MD, PhD, Study chair, Jagiellonian UniversityBogdan Batko, MD, PhD, Study chair, Department of Rheumatology, J. Dietl Hospital, Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132234
- Sponsor's protocol ID
- UJ-KChWiMWsi-Reu
- Status last verified
- May 2014
- First submitted
- 28 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02132234
- Acronym / sponsor ID
- UJ-KChWiMWsi-Reu
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (estimated)
- First posted
- 7 May 2014 (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 aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological treatment | Experimental | Drug: Etanercept, Drug: Adalimumab, Drug: Certolizumab, Drug: InfliximabPatients with high disease activity receiving biological treatment according to rheumatologic indication: * etanercept 50 mg s.c. every week * adalimumab 40 mg s.c. every 2 weeks * certolizumab 400 mg s.c. every 2 weeks for 4 weeks, then 200mg every 2 weeks * infliximab 3 or 5 mg/kg i.v. 2 and 6 weeks from the first admission, then every 8 weeks |
| control group | Placebo comparator | –Patients with high disease activity receiving other than biological treatment and receiving placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- rheumatoid arthritis diagnosed based on The American Rheumatism Association Criteria from 1987
- ineffective treatment with 2 disease-modifying antirheumatic drugs (DMARDs) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment)
- high disease activity - Disease Activity Score 28 (DAS 28) > 5,1 measured twice, with a 1-month interval
- for patients with mainly lower limbs affected with DAS 28 > 3,7
- Ankylosing Spondylitis diagnosed based on Modified New York Criteria
Key exclusion criteria (17 listed)
- non-consenting patient
- pregnancy
- breast-feeding
- allergy for the drug or any component
- cardiac insufficiency (NYHA III or IV)
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 |
|---|---|---|
| Etanerceptbiological treatment according to rheumatologic indication | Drug | Biological treatment |
| Adalimumabbiological treatment according to rheumatologic indication | Drug | Biological treatment |
| Certolizumabbiological treatment according to rheumatologic indication | Drug | Biological treatment |
| Infliximabbiological treatment according to rheumatologic indication | Drug | Biological treatment |
Primary outcome
Change from baseline in blood pressure
Time frame: prior to receiving anti-TNF-α treatment, 12 weeks
Ambulatory Blood Pressure Monitoring (ABPM)
1 secondary outcome
Change from baseline in endothelial function
Time frame: prior to receiving anti-TNF-α treatment, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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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.
Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński
Krakow, Skarbowa 4, Poland
Tomasz Guzik, MD, PhD study chair
Jagiellonian University
Bogdan Batko, MD, PhD study chair
Department of Rheumatology, J. Dietl Hospital, Krakow, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept, Adalimumab and Certolizumab in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Jagiellonian University at 1 site in Poland.
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 28 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood pressure (time frame: prior to receiving anti-TNF-α treatment, 12 weeks). 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 7 May 2014.