NL-OMON34936尚未招募2 期
A randomized, single-blind, placebo controlled, parallel-group study evaluating the anti-inflamatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis (OSM105196) - OSM105196
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 5
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
- 年龄范围
- 18 至 99（—）
入选标准
- •* Males and females, 18-75 years.
- •* Reumatoid arthritis (ACR criteria).
- •* Inflamed ankle or knee.
- •* DAS28>3.2.
- •* CRP>0.5 mg/dl.
- •* BMI 18.5-35 kg/m2.
- •* No treatment failure (efficacy) on biological in the past.
- •* At least 3 months on stable methotrexaat dose, up to 25 mg/week.
- •* At least 3 months on stable folate suppletion, at least 5 mg/week.
- •* Treatment with sulfasalazin, (OH)chloroquin, NSAIDs, oral and i.m. glucocorticosteroids conditionally accepted (for conditions, see protocol).
- •* Adequate anticonceptie voor vrouwen die kinderen kunnen krijgen en voor mannen.
排除标准
- •* Hepatitis B-C.
- •* Immuundeficiency.
- •* Prior exposure to or infection with mycobacterium tuberculosis, unless adequately treated.
- •* Acute infection.
- •* Creatinin clearance < 50 ml/min.
- •* Cyclosporin, leflonomid, cyclophosphamid, azathioprin, gold, d-penicillamine or intra-articular glucocorticosteroids in the month prior to screening.
- •* Rituximab or comparable.
- •* Live vaccinaton in the past 3 months.
- •* Zwangerschap en borstvoeding tijdens gebruik van studiemedicatie.
- •* Bleeding disorders, anaemia, peptic ulcer, GI bleeding in the past 6 months.
- •* Vitamin B12 or folate deficiency in anamnesis.
- •* Haematological disease or acquired platelet disease.
- •* Known increased risk for intra-cranial bleeding.
研究者
相似试验
进行中（未招募）
1 期
A randomized, double-blind, placebo-controlled, parallel group trial of HMR1766 assessing the efficacy and safety of 3 doses of HMR1766 (25, 100, 200 mg OD) versus placebo with cilostazol, 100 mg BID as a calibrator, administered for 26 weeks in patients with Peripheral Arterial Disease (PAD) Fontaine stage II. - ACCELAPeripheral Arterial Disease (PAD) Fontaine stage II (intermittent claudication)MedDRA version: 8.1Level: LLTClassification code 10022562Term: Intermittent claudicationEUCTR2006-004275-35-FRsanofi-aventis recherche & développement550
进行中（未招募）
不适用
A study to determine the appropriate dose(s) of Dupilumab (REGN668)in adult patients with moderate to severe atopic dermatitis (eczema)Atopic dermatitsMedDRA version: 16.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2012-003651-11-PLRegeneron Pharmaceuticals, Inc.240
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group trial of HMR1766 assessing the efficacy and safety of 3 doses of HMR1766 (25, 100, 200 mg OD) versus placebo with cilostazol, 100 mg BID as a calibrator, administered for 26 weeks in patients with Peripheral Arterial Disease (PAD) Fontaine stage II. - ACCELAPeripheral Arterial Disease (PAD) Fontaine stage II (intermittent claudication)MedDRA version: 8.1Level: LLTClassification code 10022562Term: Intermittent claudicationEUCTR2006-004275-35-ATsanofi-aventis recherche & développement550
进行中（未招募）
1 期
Efficacy and safety of dexketoprofen trometamol and tramadol hydrochloride combination on moderate to severe acute pain in patients with acute low back paiow back painMedDRA version: 21.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859EUCTR2019-003656-37-ESMenarini International Operations Luxembourg SA538
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.Rheumatoid ArthritisEUCTR2004-005210-37-DEF. Hoffmann La-Roche AG1,200