Evaluate Bone Changes in Patients With PsAPhase 4NCT04106804
Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarker
A Phase 4 study testing Abatacept 125 MG/ML in people with Evaluate Bone Changes in Patients With PsA, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Observation has pointed out, that osteitis present in the MRI scans, predicts bone erosion and that this in accordance with the concept by underlining the importance of bone marrow involvement in arthritis [Krabben A, 2013]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluate Bone Changes in Patients With PsA
- What is being tested?
- Abatacept 125 MG/ML
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2018to Aug 2022
- 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
- Males/females with CASPAR criteria-positive PsA
- Active disease with more than three swollen and tender joints
- Must be aged ≥ 18 years at time of consent
- ≥ 3 erosions on MRI or HR PQCT
- Women of childbearing potential or men capable of fathering children must be using effective contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
- Must understand and voluntarily sign an informed consent form including written consent for data protection ´- Must be able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Previous exposure to abatacept
- CCP2 positivity
- Investigational study drug within 4 weeks (or 5 halflives (half live is 14,3 days), whichever is longer) prior to randomisation
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
- Any malignancy in the last 5 years
Show all 12Show fewer
- Chronic infection such as latent TB (TB not adequately treated according to guidelines) or hepatitis B or C infection
- Immunocompromised or HIV-positive patients
- Uncontrolled severe concomitant disease
- Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG).
- Pregnant or lactating females
- Patients who possibly are dependent on the Principal Investigator or
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Erlangen, Medical Department 3, Rheumatology & Immunology
Erlangen, 91054
Dagmar Werner, +49-91318532093, dagmar.werner@uk-erlangen.de
About this study
Official title: Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarkers - ABEPSA _ BB
Observation has pointed out, that osteitis present in the MRI scans, predicts bone erosion and that this in accordance with the concept by underlining the importance of bone marrow involvement in arthritis [Krabben A, 2013]. Abatacept with its favourable safety profile preferentially interrupts activation of naïve T cells and perhaps makes the strongest case for exploiting co-stimulatory blockade during the earliest detectable phase of the adaptive immune response at a time when predisposition to autoimmune disease can be detected.
Read the detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that occurs in individuals with psoriasis. It is estimated that 1% to 3% of the general population have psoriasis.1,2,3 In Europe the prevalence of psoriasis ranges up to 6.5%.4 Between 10% and 30% of subjects with Psoriasis develop arthritis. As a result, PsA is the second most common inflammatory arthropathy, following rheumatoid arthritis (RA). 1,2,3 Psoriatic arthritis, a seronegative spondyloarthropathy, is a complex disease involving peripheral and axial joints and periarticular structures resulting in enthesitis and dactylitis. Without appropriate management, the number of joints affected by PsA and the severity of joint damage increase over time, which can lead to marked restriction of daily activities and to substantially compromised quality of life. There is evidence that active PsA is associated with accelerated atherosclerosis, obesity, metabolic syndrome and cardiovascular disease. Other co-morbidities such as pulmonary fibrosis, uveitis, and, less commonly, aortic insufficiency, also contribute to the complexity of PsA.5 Unlike RA, effective treatment options are limited for PsA. Responses to the traditional disease-modifying anti-rheumatic drugs (DMARDs) have been suboptimal.6 There is a significant unmet medical need for more effective and safe therapies in PsA, especially for reducing the arthritic signs and symptoms as well as inhibiting progression of structural damage in joints. About 20% of subjects with PsA will develop a severe destructive disabling form of arthritis.7 In the absence of definitive therapy, more than 50% of subjects with PsA will develop 5 or more deformed joints within 10 years of the onset of disease.8 TNFi therapies are efficacious for both skin and joint diseases and have been shown to inhibit structural damage, but approximately 40% of subjects treated with TNFi agents do not reach a minimal improvement [American College of Rheumatology [ACR) 20]9,10,11,12.13,14,15,16,17 In addition, serious adverse events (SAEs) including infections and injection site reactions have been associated with the use of TNFi therapies. Although in some studies a small percentage of patients previously exposed to TNFi were included, these studies were not powered to demonstrate efficacy in that sub-population. Thus, in subjects who experience inefficacy or intolerance of TNF blockade, there is still medical need for new options. Therefore, there is still need in PsA for therapies that provide significant improvement in arthritis and a risk benefit profile that is acceptable. Therapies directed at novel targets (IL-12/23, PDE4-Antagonist) are also approved since 2014. 18, 19, 20, 21 Joint involvement, is clearly the most prominent example for the systemic nature of psoriasis. Notably, the burden of joint disease in patients with psoriasis may be even higher, given that not all psoriasis patients experiencing musculoskeletal complaints fulfill the classification criteria of PsA22. If present, PsA is a severe disease associated with impaired function and reduced life quality life.
- Being tested
- Abatacept 125 MG/ML
- Keywords
- Psoriatic arthritis; Bone
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept 125 MG/MLDrug
Patients will receive weekly abatacept (Orencia®) s.c. Abatacept in the dose regimen given in the label for RA and PsA for six months
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Erosion volume
Change in bone erosion volume measured by Hr-PQ CT of the involved hand between baseline and 24 weeks follow-up
Measured: 6 months
Secondary outcomes (14)
Comparing bone Erosion baseline to week 24
Change in bone erosion on CT between baseline and 24 wks
Measured: 6 months
Comparing Osteophytes between baseline and week 24
Change in osteophytes CT between baseline and 24 wks
Measured: 3 and 6 months
Comparing Tenosynovitis between baseline, month 3 and month 6
Change in MRI Tenosynovitis score between baseline compared to month 3 and 6
Measured: 3 and 6 months
Comparing PSAMRIS score between baseline and month 3 and month 6
Change in PSAMRIS MRI score between baseline compared to month 3 and 6
Measured: 3 and 6 months
Comparing bone Erosion between baseline month 3 and and month 6 with MRI
Change in MRI bone erosions between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing Synovitis between baseline and month 3 and month 6
Change in MRI synovitis between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing DAS28 from baseline to month 3 and month 6
Change of DAS28 between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing DAPSA between baseline, month 3 and month 6
Change of DAPSA between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing MDA from baseline, month 3 and month 6
Change of MDA between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing HAQ-DI between baseline compared to month 3 and month 6
Change of HAQ-DI between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing SPARCC between baseline compared to month 3 and month 6
Change of SPARCC between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing PSAID between baseline compared to month 3 and month 6
Change of PSAID between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing PASI between baseline compared to month 3 and month 6
Change of PASI between baseline compared to month 3 and month 6
Measured: 3 and 6 months
Comparing SF36 between screening, month 3 and month 6
Change of SF36 between screening, month 3 and month 6
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start6 Jun 2018
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Bone Changes in Patients With PsAStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study is a single arm interventional study with a treatment phase of 6 months.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106804
- Sponsor's protocol ID
- ABEPSA_BB
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarkers - ABEPSA _ BB
- ClinicalTrials.gov ID
- NCT04106804
- Acronym / sponsor ID
- ABEPSA_BB
- Keywords
- Psoriatic arthritis; Bone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 Sep 2019 (actual)
- 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.
Observation has pointed out, that osteitis present in the MRI scans, predicts bone erosion and that this in accordance with the concept by underlining the importance of bone marrow involvement in arthritis [Krabben A, 2013]. Abatacept with its favourable safety profile preferentially interrupts activation of naïve T cells and perhaps makes the strongest case for exploiting co-stimulatory blockade during the earliest detectable phase of the adaptive immune response at a time when predisposition to autoimmune disease can be detected.
Detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that occurs in individuals with psoriasis. It is estimated that 1% to 3% of the general population have psoriasis.1,2,3 In Europe the prevalence of psoriasis ranges up to 6.5%.4 Between 10% and 30% of subjects with Psoriasis develop arthritis. As a result, PsA is the second most common inflammatory arthropathy, following rheumatoid arthritis (RA). 1,2,3 Psoriatic arthritis, a seronegative spondyloarthropathy, is a complex disease involving peripheral and axial joints and periarticular structures resulting in enthesitis and dactylitis. Without appropriate management, the number of joints affected by PsA and the severity of joint damage increase over time, which can lead to marked restriction of daily activities and to substantially compromised quality of life. There is evidence that active PsA is associated with accelerated atherosclerosis, obesity, metabolic syndrome and cardiovascular disease. Other co-morbidities such as pulmonary fibrosis, uveitis, and, less commonly, aortic insufficiency, also contribute to the complexity of PsA.5 Unlike RA, effective treatment options are limited for PsA. Responses to the traditional disease-modifying anti-rheumatic drugs (DMARDs) have been suboptimal.6 There is a significant unmet medical need for more effective and safe therapies in PsA, especially for reducing the arthritic signs and symptoms as well as inhibiting progression of structural damage in joints. About 20% of subjects with PsA will develop a severe destructive disabling form of arthritis.7 In the absence of definitive therapy, more than 50% of subjects with PsA will develop 5 or more deformed joints within 10 years of the onset of disease.8 TNFi therapies are efficacious for both skin and joint diseases and have been shown to inhibit structural damage, but approximately 40% of subjects treated with TNFi agents do not reach a minimal improvement [American College of Rheumatology [ACR) 20]9,10,11,12.13,14,15,16,17 In addition, serious adverse events (SAEs) including infections and injection site reactions have been associated with the use of TNFi therapies. Although in some studies a small percentage of patients previously exposed to TNFi were included, these studies were not powered to demonstrate efficacy in that sub-population. Thus, in subjects who experience inefficacy or intolerance of TNF blockade, there is still medical need for new options. Therefore, there is still need in PsA for therapies that provide significant improvement in arthritis and a risk benefit profile that is acceptable. Therapies directed at novel targets (IL-12/23, PDE4-Antagonist) are also approved since 2014. 18, 19, 20, 21 Joint involvement, is clearly the most prominent example for the systemic nature of psoriasis. Notably, the burden of joint disease in patients with psoriasis may be even higher, given that not all psoriasis patients experiencing musculoskeletal complaints fulfill the classification criteria of PsA22. If present, PsA is a severe disease associated with impaired function and reduced life quality life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- The study is a single arm interventional study with a treatment phase of 6 months.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males/females with CASPAR criteria-positive PsA
- Active disease with more than three swollen and tender joints
- Must be aged ≥ 18 years at time of consent
- ≥ 3 erosions on MRI or HR PQCT
- Women of childbearing potential or men capable of fathering children must be using effective contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
Key exclusion criteria (12 listed)
- Previous exposure to abatacept
- CCP2 positivity
- Investigational study drug within 4 weeks (or 5 halflives (half live is 14,3 days), whichever is longer) prior to randomisation
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
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 |
|---|---|---|
| Abatacept 125 MG/MLPatients will receive weekly abatacept (Orencia®) s.c. Abatacept in the dose regimen given in the label for RA and PsA for six months | Drug | – |
Primary outcome
Bone Erosion volume
Time frame: 6 months
Change in bone erosion volume measured by Hr-PQ CT of the involved hand between baseline and 24 weeks follow-up
14 secondary outcomes
Comparing bone Erosion baseline to week 24
Time frame: 6 months
Comparing Osteophytes between baseline and week 24
Time frame: 3 and 6 months
Comparing Tenosynovitis between baseline, month 3 and month 6
Time frame: 3 and 6 months
Comparing PSAMRIS score between baseline and month 3 and month 6
Time frame: 3 and 6 months
Comparing bone Erosion between baseline month 3 and and month 6 with MRI
Time frame: 3 and 6 months
Comparing Synovitis between baseline and month 3 and month 6
Time frame: 3 and 6 months
Comparing DAS28 from baseline to month 3 and month 6
Time frame: 3 and 6 months
Comparing DAPSA between baseline, month 3 and month 6
Time frame: 3 and 6 months
Comparing MDA from baseline, month 3 and month 6
Time frame: 3 and 6 months
Comparing HAQ-DI between baseline compared to month 3 and month 6
Time frame: 3 and 6 months
Comparing SPARCC between baseline compared to month 3 and month 6
Time frame: 3 and 6 months
Comparing PSAID between baseline compared to month 3 and month 6
Time frame: 3 and 6 months
Comparing PASI between baseline compared to month 3 and month 6
Time frame: 3 and 6 months
Comparing SF36 between screening, month 3 and month 6
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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.
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 Abatacept 125 MG/ML in people with Evaluate Bone Changes in Patients With PsA, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 6 inclusion and 12 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 27 Sep 2019. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juergen Rech, MD (+49-91318543014, juergen.rech@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Erosion volume (time frame: 6 months). 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 27 Sep 2019.