Strategy Treatments Aiming at Minimal Disease Activity (MDA) in Psoriatic Arthritis

Phase 1

• Conditions: Oligo and polyarticular psoriatic arthritis.; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-004724-11-NL
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-08
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. A new diagnosis of PsA as per CASPAR criteria <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. In the Investigator’s opinion, the patient is able and willing to comply to all trial requirements.
6. 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.

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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. Use of any investigational drug and/or devices within 4 weeks prior to randomization or a period of five half-lives of the investigational drug, whichever is longer in duration.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. History of renal trauma, glomerulonephritis, or subjects with one kidney only, or a glomerular filtration rate (GFR) < 30 ml/min.
10. Active systemic infections during the last two weeks (exception: common cold) prior to randomization.
11. 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.
12. Known infection with human immunodeficiency virus, hepatitis B or hepatitis C at screening or randomization.
13. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified