ISRCTN31164692进行中（未招募）2 期
Pharmacodynamic activity trial of JNJ-67484703 in rheumatoid arthritis, ulcerative colitis and Sjögren’s syndrome (PARIS): a phase II proof of biology trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Main inclusion criteria for all cohorts:
- •1. Informed consent must be obtained provided prior to any trial-related procedures being performed
- •2. Male and female participants aged =18 and =75 years at the time of enrolment
- •3. Able to communicate well with the investigator, and to understand and comply with the requirements of the trial
- •4. Willing to have repeat tissue biopsy relevant to disease group (ultrasound-guided synovial biopsy, minor salivary gland biopsy or endoscopic colonic mucosal biopsy)
- •5. Body weight within the range of 45.0 kg to 120.0 kg, inclusive
- •Inclusion criteria for patients with rheumatoid arthritis (RA):
- •6. Confirmed clinical diagnosis of RA
- •7. Active RA
- •8. Joint amenable to biopsy by ultrasound criteria
- •9. Autoantibody positive
- •10. Have methotrexate (MTX) inadequate response
- •11. If using regular non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose
- •Inclusion criteria for patients with ulcerative colitis (UC):
- •12. Confirmed clinical diagnosis of UC
- •13. Moderately to severely active UC on endoscopy
- •15. Either primary non-response or secondary loss of response to one or more biologic or targeted synthetic therapies
- •16. Medications/therapies must have been discontinued by the number of stated weeks before Visit 2 (Baseline) as outlined in the protocol.
- •17. A participant =45 years of age must have had a full colonoscopy. Adenomatous polyps must be removed before the first dose of trial intervention
- •18. A participant who has had extensive colitis for =8 years, or disease limited to the left side of the colon for =10 years, must have or have had a full colonoscopy to assess for the presence of dysplasia or malignancy at the Screening Visit
- •Inclusion criteria for patients with Sjögren’s syndrome (SjS):
- •19. A diagnosis of SjS, according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
- •20. Autoantibody positive
- •21. At least low activity” in the biological domain of EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI)
- •22. ESSPRI component scores as outlined in the protocol
- •23. Residual stimulated whole salivary flow
排除标准
- •Main exclusion criteria for all cohorts:
- •1. Prior B cell depletion
- •2. Other biologic therapy or targeted synthetic disease-modifying antirheumatic drugs (DMARDs)
- •3. Receipt of any investigational medicinal product within 16 weeks, or approximately 5 half-lives (whichever is longer) prior to Visit 2 (baseline)
- •4. Any active or ongoing viral, bacterial or other infections
- •5. Confirmed, suspected, or close contact with a person with known or suspected SARS-CoV-2 infection
- •6. Major organ, haematopoietic stem cell or bone marrow transplant
- •7. Any cancer within the previous 5 years,
- •8. Severe, uncontrolled fibromyalgia symptoms.
- •9. Treatment with glucocorticoids unless on a stable dose of prednisolone
- •10. Positive test for HIV, Hepatitis C Virus or Hepatitis B Virus
- •11. Active cytomegalovirus (CMV) or Epstein–Barr virus (EBV)
- •12. Live vaccine within 12 weeks of registration
- •13. Bacillus Calmette-Guérin (BCG) vaccination within 12 months prior to trial drug administration.
- •14. Evidence of active or latent tuberculosis (TB)
- •15. Has known allergies, hypersensitivity, or intolerance to JNJ-67484703 or its excipients
- •16. Any medical, surgical or psychiatric condition that the investigator believes may jeopardise the participant, or the validity of the trial results, were they to participate in the trial
- •17. Has experienced myocardial infarction, unstable ischaemic heart disease, or stroke within 12 weeks of Screening Visit
- •18. Female who is pregnant, breastfeeding, intends to become pregnant or is of childbearing potential, not willing to use highly effective contraceptive methods
- •19. A non-vasectomised male participant who refuses to wear a condom during the trial and for 14 weeks after the last dose of trial treatment when engaging in any activity that allows for passage of ejaculate to another person. An additional method of highly effective method of contraception must also be used.
- •20. A male participant must agree not to donate sperm for the purpose of reproduction during the trial and for a minimum 14 weeks after receiving the last dose of the trial intervention
- •21. Screening laboratory test results as specified in the protocol
- •22. Advised by clinician not to have a tissue biopsy due to clinical reasons or anti-coagulant use
- •23. Septic arthritis of a native or prosthetic joint in the last 12 months (or indefinitely if the prosthetic joint remains in situ)
- •Exclusion criteria for patients with rheumatoid arthritis:
- •24. History of or current inflammatory joint disease other than RA
- •25. Currently taking anticoagulant medications (not anti-platelet agents) that would contraindicate synovial biopsy
- •26. DMARD or other immunosuppressive therapy with the exception of methotrexate, sulfasalazine or hydroxychloroquine at stable doses
- •Exclusion criteria for patients with ulcerative colitis:
- •27. History of severe extensive colitis
- •28. Has UC limited to the rectum only
- •29. Presence or history of a fistula
- •30. History of colonic mucos
研究者
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