EUCTR2010-018485-24-ES进行中（未招募）1 期
A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 128
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
- •To participate in this trial, patients must meet all the following criteria:
- •1. Written informed consent
- •2. Patients of both gender with active RA according to 1987 revised American
- •College of Rheumatology (ACR) criteria with functional class II-III
- •3. Disease activity at screening and baseline:
- •a.= 6 swollen joints on 66 joint count and
- •b.= 6 tender joints on 68 joint count and
- •c.= 1 out of the 2 criteria:
- •i.erythrocyte sedimentation rate (ESR)
- •male, = 50 years: = 23 mm/H
- •male, > 50 years: = 30 mm/H
- •female, = 50 years: = 30 mm/H
- •female: > 50 years: = 45 mm/H
- •ii.C-reactive protein (CRP) = 8 mg/L
- •4. Duration of RA = 12 months
- •5. Aged 18 years - 75 years (extremes included)
- •6. Body mass index (BMI) 18 kg/m2 - 30 kg/m2 (extremes included)
- •7. History of at least one traditional disease modifying anti-rheumatic drug (DMARD) with an inadequate response despite = 3 months of treatment
- •8. Oral or parenteral MTX treatment for = 6 months with an unchanged mode of application and stable MTX dose = 15 mg (or = 10 mg in case of MTX intolerance) and = the upper limit of the applicable Summary of Product Charac-teristics (SmPC) for at least 8 weeks prior to baseline
- •9. Patients could continue to receive = 7.5 mg daily of oral corticosteroids (prednisone or equivalent) at the same dose received prior to the study if dose was stable for = 6 weeks prior to baseline, if applicable
- •10. Patients could continue to receive non-steroidal antiinflam-matory drugs (NSAIDs) at the same dose as received prior to the study if dose was stable for = 2 weeks prior to baseline, if applicable
- •11. No acute or clinically relevant abnormalities in electrocar-diogram (ECG; 12-lead) at screening and baseline
- •12. The following blood test results must be fulfilled at screen-ing:
- •a.Hemoglobin = 8.5 g/dL
- •b.Hematocrit > 30%
- •c.White blood cells (WBC) > 3.5*10E9 cells/L
- •d.Neutrophils = 1.5*10E9 cells/L
- •e.CD4 > 0.4*10E9 cells/L
- •f.B-cell count (CD19 count) > 75% of the lower limit of normal range (LLN)
- •g.Platelets = 150*10E9 cells/L
- •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
- •1. Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and for DMARD leflunomide 24 weeks (except specific leflunomide wash out proce-dure, i. e. 11 days with colestyramine or activated charcoal plus 30 days wash-out ) prior to baseline
- •2. Treatment with any biologics other than TNF-a inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
- •3. Treatment with any TNF-a inhibitor within 5 elimination half-lives prior to baseline (e.g. certolizumab 10 weeks, adalimumab 10 weeks, etanercept 3 weeks, infliximab 7 weeks, golimumab 10 weeks) and during the study
- •4. Clinical non-response to more than one previous TNF-a inhibitor treatment exceeding adequate treatment duration
- •5. Serious adverse drug reaction to previous biological treat-ment
- •6. Intra-articular, intramuscular, or intravenous corticosteroid treatment within 4 weeks prior to screening and during the study
- •7. Previous therapy with CD4 monoclonal antibody (mab) BT061
- •8. Serum transaminases, alanine transaminase (ALAT) and/or aspartate transaminase (ASAT) > 2.5 fold ULN at screening
- •9. Bilirubin > 3 mg/dL at screening
- •10. Alkaline phosphatase > 2 fold ULN at screening
- •11. Urea nitrogen > 1.5 fold ULN at screening
- •12. Kidney insufficiency as defined by creatinine level > 1.5 mg/dl at screening
- •13. History of severe allergic or anaphylactic reaction to pro-teins of human origin (e.g. vaccination reaction, biological therapy)
- •14. Presence or history of malignancy within the previous 5 years (except completely resected squamous or basal cell carcinoma of the skin)
- •15. Presence or history of clinically significant major disease (e.g. severe heart/lung disease New York Heart Associa-tion [NYHA] Class = 3, autoimmune disease [apart from rheumatoid arthritis], acute uncontrolled hyper- or hypo-thyreoidism, severe uncontrolled hypo- or hypertension)
- •16. Serious local (e.g. abscess) or systemic (e.g. pneumonia, septicemia) infection or recurrent chronic infections within 6 weeks prior to screening visit or during the screening period
- •17. Any infection requiring antibiotic therapy by any route of administration within 2 weeks prior to baseline
- •18. Vaccination with live, live attenuated, and/or killed vac-cines in the 12 weeks prior to the first administration of the study drug and during the study
- •19. Positive diagnosis for acute or chronic infections (i.e. He-patitis C Virus [HCV], Hepatitis B Virus [HBV], Human Im-munodeficiency Virus [HIV]) at Screening visit or history of previous chronic infection
- •20. Acute or clinically symptomatic Epstein-Barr Virus (EBV) (infectious mononucleosis) or Cytomegalovirus (CMV) in-fection
- •21. Presence or history of latent or active tuberculosis
- •22. Presence or history of recurrent acute inflammatory joint disease other than RA
- •23. Known immune deficiency
- •24. Presence or history of lymphoproliferative disease, includ-ing lymphoma and lymphadenopathy
- •25. Presence or history of clinically significant drug or alcohol abuse
- •26. Joint surgery within 2 months prior to screening
- •27. The patient, planned to be enrolled, is an employee of any involved study investigator or any involved institution in-cluding the study sponsor
- •28. Pregnant or nursing women or women of childbearing potential (unless surgically sterile) who are not using two independent effective contraceptive methods during the study and for at least 3 months after the last administration of study drug (e.g. oral or injectable contraceptives, intrauterine devices, double
研究者
相似试验
进行中（未招募）
1 期
A medical research study to evaluate the effects of ACT-246475 in adults with coronary artery disease.stable coronary artery diseaseMedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersEUCTR2017-003332-36-DKIdorsia Pharmaceuticals Ltd.324
进行中（未招募）
不适用
A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic SclerosisEUCTR2014-000865-34-GBActelion Pharmaceuticals Ltd70
进行中（未招募）
不适用
A multi-center, double-blind, randomized, placebo-controlled, dose-ranging phase 2 study to investigate pharmacodynamics, safety, tolerability and pharmacokinetics of RO5073031 in patients with type 2 diabetes mellitus treated with a stable dose of metformin (BC20688)Type 2 diabetes mellitusMedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitusEUCTR2006-004407-19-DEF. Hoffmann-La Roche Ltd264
进行中（未招募）
1 期
A medical research study to evaluate the effects of ACT-246475 in adults with coronary artery disease.stable coronary artery diseaseMedDRA version: 20.0Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersEUCTR2017-003332-36-NLIdorsia Pharmaceuticals Ltd.324
进行中（未招募）
1 期
Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.MedDRA version: 18.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEisenmenger SyndromeEUCTR2012-003335-33-CZActelion Pharmaceuticals Ltd.220