Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarker
Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarkers - ABEPSA _ BB
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- ABEPSA_BB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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