Psoriatic arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Orencia prefilled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Females and males aged = 18 years at time of consent Classification of Psoriasis arthritis according to CASPAR criteria Active arthritis with more than 2 swollen and tender joints >=1 erosion at the Metacarpophalangeal Joint 2 or 3 detected by Imaging (Hand MRI or HR PQCT) cDMARD inadequate responders (e.g. methotrexate failure or any other failure to cDMARD therapy) or cDMARD intolerance; Exception: in subjects who were previously treated with tsDMARD (e.g. Apremilast) or bDMARD (e.g. Guselkumab) due to their Psoriasis Involvement as a first line therapy, cDMARD Treatment failure/intolerance is not a mandatory requirement. Subjects who have been previously been treated with bDMARD or tsDMARD will be allowed entry into study after an appropriate wash-out period prior to baseline: bDMARDs: - Adalimumab: 6 weeks or longer (average half-life 2 weeks) - Certolizumab: 6 weeks or longer (half-life approx. 14 days) - Etanercept: 3 weeks or longer (half-life approx. 70 hours) - Golimumab: 6 weeks or longer (half-life 12 + 3 days) - Infliximab: 7 weeks or longer (half-life 8-9,5 days) - Secukinumab: 12 weeks or longer (average half-life 27 days) - Ustekinumab: 12 weeks or longer (half life up to 32 days) - Guselkumab: 6 weeks or longer (half life up to 18 days) tsDMARDs: - Tofacitinib: 1 week or longer (half-life 3 hours) - Apremilast: 1 week or longer (half life up to 9 hours) - Baricitinib: 1 week or longer (half life up to 12,5 hours) - Upadacitinib: 1 week or longer (half life upp to 14 hours) - For other bDMARD not mentioned above the wash-out period should be at least three times the half-life of the bDMARD concerned. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Indication for systemic treatment for the skin other than DMARD`s Any contraindications for abatacept Current Treatment with bDMARDs Previous exposure to abatacept Investigational study drug within 4 weeks (or 5 halflifes (one half life is 14,3 days), whichever is longer) prior to enrolment 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 Investigator (e.g. family members)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of abatacept on erosive bone changes in patients with PsA for up to 24 weeks;Secondary Objective: To evaluate the effects of abatacept on signs of inflammation in patients with PsA from baseline compared to week 12 and week 24;Primary end point(s): Change in bone erosion volume at the second and third metacarpophalangeal (MCP) joint measured by Hr-pQCT at week 24 compared to baseline ;Timepoint(s) of evaluation of this end point: Baseline, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of new erosions at second and third MCP joint at week 24 using HR-pQCT Number of new osteophytes in MCP joints at week 24 using HR-pQCT Number of new bone erosions at week 12 and week 24 compared to baseline using Hand MRI Change in tenosynovitis score between baseline and week 12 and week 24 using Hand MRI Change in PsAMRIS between baseline and week 12 and week 24 using Hand MRI Change in synovitis between baseline and week 12 and week 24 using Hand MRI Change in DAS28 (ESR) between baseline and week 12 and week 24 Change in DAPSA between baseline and week 12 and week 24 Change in MDA between baseline and week 12 and week 24 Change in HAQ-DI between baseline and week 12 and week 24 Change in SPARCC between baseline and week 12 and week 24 Change in PSAID between baseline and week 12 and week 24 Change in PASI between screening, baseline, week 12 and week 24;Timepoint(s) of evaluation of this end point: Baseline, Week 12, Week 24 | — |
Countries
Germany
Contacts
Public ContactMedizinische Klinik 3
Universitätsklinikum Erlangen
Outcome results
None listed