E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effects of abatacept on erosive bone changes in patients with PsA for up to 24 weeks |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effects of abatacept on signs of inflammation in patients with PsA from baseline compared to week 12 and week 24 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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)
|
|
E.5 End points |
E.5.1 | 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
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, Week 12, Week 24 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |