- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106804
Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarker
September 25, 2019 updated by: University of Erlangen-Nürnberg Medical School
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juergen Rech, MD
- Phone Number: +49-91318543014
- Email: juergen.rech@uk-erlangen.de
Study Locations
-
-
-
Erlangen, Germany, 91054
- Recruiting
- University Clinic Erlangen, Medical Department 3, Rheumatology & Immunology
-
Contact:
- Dagmar Werner
- Phone Number: +49-91318532093
- Email: dagmar.werner@uk-erlangen.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparing bone Erosion baseline to week 24
Time Frame: 6 months
|
Change in bone erosion on CT between baseline and 24 wks
|
6 months
|
Comparing Osteophytes between baseline and week 24
Time Frame: 3 and 6 months
|
Change in osteophytes CT between baseline and 24 wks
|
3 and 6 months
|
Comparing Tenosynovitis between baseline, month 3 and month 6
Time Frame: 3 and 6 months
|
Change in MRI Tenosynovitis score between baseline compared to month 3 and 6
|
3 and 6 months
|
Comparing PSAMRIS score between baseline and month 3 and month 6
Time Frame: 3 and 6 months
|
Change in PSAMRIS MRI score between baseline compared to month 3 and 6
|
3 and 6 months
|
Comparing bone Erosion between baseline month 3 and and month 6 with MRI
Time Frame: 3 and 6 months
|
Change in MRI bone erosions between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing Synovitis between baseline and month 3 and month 6
Time Frame: 3 and 6 months
|
Change in MRI synovitis between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing DAS28 from baseline to month 3 and month 6
Time Frame: 3 and 6 months
|
Change of DAS28 between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing DAPSA between baseline, month 3 and month 6
Time Frame: 3 and 6 months
|
Change of DAPSA between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing MDA from baseline, month 3 and month 6
Time Frame: 3 and 6 months
|
Change of MDA between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing HAQ-DI between baseline compared to month 3 and month 6
Time Frame: 3 and 6 months
|
Change of HAQ-DI between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing SPARCC between baseline compared to month 3 and month 6
Time Frame: 3 and 6 months
|
Change of SPARCC between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing PSAID between baseline compared to month 3 and month 6
Time Frame: 3 and 6 months
|
Change of PSAID between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing PASI between baseline compared to month 3 and month 6
Time Frame: 3 and 6 months
|
Change of PASI between baseline compared to month 3 and month 6
|
3 and 6 months
|
Comparing SF36 between screening, month 3 and month 6
Time Frame: 3 and 6 months
|
Change of SF36 between screening, month 3 and month 6
|
3 and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2018
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (Actual)
September 27, 2019
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Spondylarthritis
- Spondylitis
- Psoriasis
- Arthritis
- Arthritis, Psoriatic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Immune Checkpoint Inhibitors
- Abatacept
Other Study ID Numbers
- ABEPSA_BB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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