NL-OMON55356RecruitingPhase 4
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. - STAMP
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites120 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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
- •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
Investigators
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