Clinical effectiveness of 2 treat to target strategies, mimicking standard care compared to early secukinumab for the treatment of Moderate to Severe Psoriatic arthritis: a parallel group randomised controlled trial.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. A new diagnosis of PsA as per CASPAR criteria at least 3 months.
2. A minimum of two swollen joints.
3. Patients must be able to understand and communicate with the Investigator
and comply with the requirements of the study and must give a written, signed
and dated informed consent before any study assessment is performed.
4. Male or female patients between 18 and 80 years of age.
5. Female participants of child bearing potential and male participants whose
partner is of child bearing potential must be willing to ensure that they or
their partner use effective contraception during the trial and for 3 months
thereafter as in standard practice.

Exclusion Criteria

1. Evidence of ongoing infectious or malignant process obtained within 3 months
prior to screening and evaluated by a qualified health care professional.
2. Current or previous treatment of arthritis with DMARDs (including
methotrexate, leflunomide or sulfasalazine) or biologics (including TNF,
IL12/23 or IL17 inhibitor therapies)
3. Pregnant or nursing (lactating) women, in which pregnancy is defined as the
state of a female after conception and until the termination of gestation,
confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
4. Women of child-bearing potential, defined as all women physiologically
capable of becoming pregnant, unless they are using effective methods of
contraception during dosing of study drug.
5. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic,
endocrine, cardiac, infectious or gastrointestinal conditions which in the
opinion of the Investigator immunocompromises the patient and/or places the
patient at unacceptable risk for participation in an immunomodulatory therapy.
6. Significant medical problems or diseases, including but not limited to the
following: uncontrolled hypertension (>= 160/95 mmHg), congestive heart failure
(New York Heart Association status of class III or IV), and uncontrolled
diabetes.
7. History of clinically significant liver disease or liver injury as indicated
by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum
glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum
glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum
bilirubin. The Investigator should be guided by the following criteria: Any
single parameter may not exceed 2 x upper limit of normal (ULN). A single
parameter elevated up to and including 2 x ULN should be re-checked once more
as soon as possible, and in all cases, at least prior to
enrollment/randomization, to rule out laboratory error.
8. History of renal trauma, glomerulonephritis, or subjects with one kidney
only, or a glomerular filtration rate (GFR) < 30 ml/min.
9. Active systemic infections during the last two weeks (exception: common
cold) prior to randomization.
10. History of ongoing, chronic or recurrent infectious disease or evidence of
tuberculosis infection as defined by either a positive PPD skin test or a
positive QuantiFERON TB-Gold test untreated or insufficiently treated according
to the national guideline.
11. Known infection with human immunodeficiency virus, hepatitis B or hepatitis
C at screening or randomization.
12. History of lymphoproliferative disease or any known malignancy or history
of malignancy of any organ system within the past 5 years (except for basal
cell carcinoma or actinic keratoses that have been treated with no evidence of
recurrence in the past 3 months, carcinoma in situ of the cervix or
non-invasive malignant colon polyps that have been removed).
13. Current severe progressive or uncontrolled disease, which in the judgment
of the clinical Investigator renders the patient unsuitable for the trial.
14. Inability or unwillingness to undergo repeated venipuncture (e.g. because
of poor tolerability or lack of access to veins).
15. Any medical or psychiatric condition which, in the Investigator*s opinion,
would preclude the participant f

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The ACR50 response will be used to determine efficacy at 6 months. A subject is<br /><br>defined as an ACR50 responder if, and only if, the following three conditions<br /><br>are met:<br /><br><br /><br>1. they have a >= 50% improvement in the number of tender joints (based on 68<br /><br>joints)<br /><br>2. they have a >= 50% improvement in the number of swollen joints (based on 66<br /><br>joints)<br /><br>3. they have a >= 50% improvement in three of the following five domains:<br /><br>- Patients global assessment of disease activity (measured on a VAS scale,<br /><br>0-100)<br /><br>- Physicians global assessment of disease activity (measured on a VAS scale,<br /><br>0-100)<br /><br>- Patient*s assessment of PsA pain (measured on a VAS scale, 0-100)<br /><br>- Health Assessment Questionnaire - Disability Index (HAQ-DI©) score<br /><br>- Acute phase reactant (hsCRP or ESR)</p><br>

Secondary Outcome Measures