Treatment strategies aiming at minimal disease activity in psoriatic arthritis
- Conditions
- Psoriatic arthritisArthropathic psoriasisSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN76054545
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 120
1. Newly diagnosed by the rheumatologist and fulfilling the Classification criteria for Psoriatic Arthritis (CASPAR)
2. Present with oligo-arthritis (2 to 5 involved joints) or with poly-arthritis (5 or more 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
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 MTX, 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. 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) of e.g. aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, and/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 Purified Protein Derivative (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 from adhering to the protocol or completing the study per protocol.
16. History or evidence of ongoing alcohol or drug abuse, within the last 6 months before randomizat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease activity measured using the ACR50 at 6 months
- Secondary Outcome Measures
Name Time Method 1. Disease activity measured using the ACR 20 and 70 at 6 months <br>2. Disease activity measured using the ACR 20, 50, 70 at 12 months <br>3. Disease activity measured using MDA and Very low disease activity (VLDA) at 6 and 12 months <br>4. Disease activity. measured using Disease Activity in Psoriatic Arthritis (DAPSA) score at 6 and 12 months <br>5. Disease activity. measured using Psoriatic Arthritis Disease Activity Score (PASDAS) score at 6 and 12 months <br>6. General health measured using the Short-form 36 at 12 months<br>7. Impact of disease measured using Psoriatic Arthritis Impact of Disease (PSAID) at 12 months <br>8. Fatigue measured using Bristol Rheumatoid Arthritis Fatigue (BRAF) at 12 months