EUCTR2008-007346-63-GB进行中（未招募）不适用
Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The total cohort of patients is small, only 10 patients. We will attempt to make the population as homogenous as possible.
- •1.12Inclusion Criteria
- •1. Male or non-pregnant, non-lactating female patients of any race with an age >18 years. Woman of child-bearing potential must be on regular contraceptives throughout the trial. Pregnancy tests will be used at screening for women of child bearing years.
- •1A: RA according to the 1987 revised ARA criteria (Arnett 1987) with an active disease with DAS28>3.2 despite the prior or concurrent use of DMARDs.
- •2. Patients may be on no active therapy or may be on continuous DMARD therapy including Methotrexate, Sulphasalazine, Leflunomide, Hydroxychloroquine, Myocrisin alone or in combination, or on NSAID treatment, or on steroid (prednisolone not more than 10mg/day) provided that the regime has been stable for 30 days prior to screening. All prior medication should be maintained at steady dosing throughout the 8th day laboratory phase. Intra-articular or subcutaneous steroid are not allowed during the laboratory phase. Alterations may be made at the discretion of the investigator during the 3-month clinical follow-up period in accordance with standard of care. All such alterations will be recorded and reported. Joints receiving IA injections will be counted as positive for subsequent tender and swollen joint counts.
- •3. Patients must have a measurable acute phase response: CRP (> 10mg/dl)or ESR > 25. (to be measured on routine lab range CRP/ ESR/AP/ standard biochemistry)
- •4. Patients eligible for treatment with biological TNFa blockers and who are awaiting the administration of such treatment may enrol in the laboratory and safety protocols Data for Clinical Phase observations will be collected but will be handled as last observation carried forward for the final records prior to the administration of TNF blocking agent, should that occur within the 3-month Clinical Phase. The administration of TNFa blockers will not be delayed for the protocol.
- •5. Patients who have given written informed consent prior to participation in
- •the trial and who undertake to comply with the protocol.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •1. Patients who are unwilling or unable to be fully evaluated for follow-up.
- •2. Patients who have an active infection or who are suspected of having systemic infection and or patients that are treated with antibiotics.
- •3. Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 34.2 umol/L (> 2.0 mg/dL), ALT (>120) or AST (>135) corresponding to > 3X upper limit of normal.
- •4. Alkaline phosphatase levels must be less 145 IU/L (routine clinical method)and patients with too low observed acute phase rsponse (ESR/CRP) on screening bloods.
- •5. Patients who received investigational drugs in the 30 days prior to study drug administration, or are currently participating in a study during which
- •the administration of investigational drugs within one month is anticipated.
- •6. Patients who have renal insufficiency (history of creatinine >177umol/L or >2.0 mg/dL) or chronic renal failure requiring dialysis.
- •7. Patients with severe neurological deficits (see Appendix I).
- •8. Patients who have a recent history of drug substance or alcohol abuse.
- •9. Patients with a diagnosis of idiopathic thrombocytopenia.
- •10. Patients with a history of cancer who have received chemotherapy or radiation therapy within the past 3 months. Patients receiving only adjuvant hormonal therapy are not excluded. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys.
- •11. Patients receiving oral glucocorticoids >10mg /day or any IV, IM or Intra articular dosing within 30 days of commencing the protocol.
- •12. Patients who are vegetarians or veganists or those patients that may be expected not to be tolerant to bovine proteins.
- •13. Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study.
研究者
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