Ankylosing SpondylitisPhase 4NCT02492217
Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients
A Phase 4 study testing Adalimumab in people with Ankylosing Spondylitis, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 sitePortugal
- Study dates
- May 2015to 28 May 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AS according to Portuguese Society of Rheumatology (SPR) guidelines (1984 modified New York Criteria, but allowing the use of MRI as imagiological criteria)
- Patient enrolment followed national guidelines for TNF antagonist use for the treatment of AS
- Adults between 18 to 75 years
- Ability to provide informed consent
- Corticosteroid therapy allowed (equivalent to ≤ 10 mg prednisone) and / or NSAID(nonsteroidal antiinflammatory drug), stable dose in 4 weeks before study initiation
- Adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners
- Adequate renal and hepatic function (2 times ULN)
Who cannot join
- Current pregnancy or breastfeeding
- Previous treatment with biologic DMARD's (disease-modifying antirheumatic drug)
- Intraarticular injections or infiltrations of extraaxial joints and tendons within 28 days before or at screening, or intraarticular injections of sacroiliac joints ≤ 28 days before screening
- History of rheumatic disorder other than AS
- Other forms of spondylarthritis than AS
- Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease)
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- History or signs of demyelinating disease
- Malignancy (except for completely treated squamous or basal cell carcinoma)
- Moderate to severe heart failure (NYHA class III/IV) Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus
- Active or latent tuberculosis (TB) or histoplasmosis or other severe infections such as sepsis, and opportunistic infections
- Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment
- Ankylosis of the spine (syndesmophytes presence at all levels from D12 to S1 in X-ray (XR) lateral view)
- Hypersensitivity to the active substance or to any of the excipients
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Ciências Médicas da Universidade Nova de Lisboa
Lisbon
About this study
Official title: Biomarkers Identification of Anti-TNF α Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry
To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Adalimumab
- Keywords
- Ankylosing Spondylitis, adalimumab, TNF-alpha agents, spondyloarthritis, biologic therapies, AS, biomarkers, efficacy prediction
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Adalimumab will be provided to trial participants as 0.8 ml single dose pre-filled syringes containing 40mg adalimumab each. A kit will be dispensed to he subject every two weeks, each kit containing one syringe. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)
To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.
Measured: 14 weeks
Secondary outcomes (2)
QoL evaluation
To evaluate quality of life using ASQOL and SF-36 questionnaires
Measured: 14 weeks
MRI progression
Rachis evaluation according to acute and structural lesions
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018
- Study completion28 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando M. Pimentel-Santos, MD, PhD, Study chair, NOVA Medical School/Faculdade de Ciências MédicasJaime C. Branco, MD, PhD, Principal investigator, NOVA Medical School/Faculdade de Ciências Médicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492217
- Sponsor's protocol ID
- UniversidadeNL
- Status last verified
- Oct 2020
- First submitted
- 3 Jul 2015
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Identification of Anti-TNF α Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry
- ClinicalTrials.gov ID
- NCT02492217
- Acronym / sponsor ID
- UniversidadeNL
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, adalimumab, TNF-alpha agents, spondyloarthritis, biologic therapies, AS, biomarkers, efficacy prediction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 8 Jul 2015 (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.
To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: AdalimumabAdalimumab will be provided to trial participants as 0.8 ml single dose pre-filled syringes containing 40mg adalimumab each. A kit will be dispensed to he subject every two weeks, each kit containing one syringe. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- AS according to Portuguese Society of Rheumatology (SPR) guidelines (1984 modified New York Criteria, but allowing the use of MRI as imagiological criteria)
- Patient enrolment followed national guidelines for TNF antagonist use for the treatment of AS
- Adults between 18 to 75 years
- Ability to provide informed consent
- Corticosteroid therapy allowed (equivalent to ≤ 10 mg prednisone) and / or NSAID(nonsteroidal antiinflammatory drug), stable dose in 4 weeks before study initiation
Key exclusion criteria (13 listed)
- Current pregnancy or breastfeeding
- Previous treatment with biologic DMARD's (disease-modifying antirheumatic drug)
- Intraarticular injections or infiltrations of extraaxial joints and tendons within 28 days before or at screening, or intraarticular injections of sacroiliac joints ≤ 28 days before screening
- History of rheumatic disorder other than AS
- Other forms of spondylarthritis than AS
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 |
|---|---|---|
| Adalimumab | Drug | Adalimumab |
Primary outcome
Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 14 weeks
To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.
2 secondary outcomes
QoL evaluation
Time frame: 14 weeks
MRI progression
Time frame: 14 weeks
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 3 Nov 2020.
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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.
Fernando M. Pimentel-Santos, MD, PhD study chair
NOVA Medical School/Faculdade de Ciências Médicas
Jaime C. Branco, MD, PhD principal investigator
NOVA Medical School/Faculdade de Ciências Médicas
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 Adalimumab in people with Ankylosing Spondylitis, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 7 inclusion and 13 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 3 Nov 2020. 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 Portugal. 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. 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?
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?
Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS) (time frame: 14 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 3 Nov 2020.