EUCTR2010-022049-88-DE进行中（未招募）不适用
Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI
相关药物
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
- •1.Patients at baseline with active rheumatoid arthritis (RA) and a DAS28 (ESR) of >3.2 and of =6 months duration, diagnosed according to the ACR (American College of Rheumatology) criteria of 1987.
- •2.Patients able and willing to give written informed consent to participate and comply with the requirements of the study; in addition, written consent for data protection (legal requirement in Germany: Datenschutz-rechtliche Einwilligung) must be provided.
- •3.Receiving treatment on an outpatient basis.
- •4.Age =18 years.
- •5.At screening and/or baseline either ESR =28mm/h or CRP =0.7mg/dL (SI: =7mg/L).
- •6.Receiving permitted DMARDs, one or more; current DMARD therapy must have been at a stable dose for at least 4 weeks prior to baseline.
- •7.Oral corticosteroids (=10mg/day prednisone or equivalent) are permitted if dose was stable for at least 4 weeks prior to baseline.
- •8.Women of child-bearing potential are allowed to participate in this trial only if using reliable, highly effective contraceptives (allowed methods of birth control, i.e. with a failure rate of less than 1 % per year, are implants, injectables, combined oral contraceptives, IUSs (only hormonal contraceptive coil), sexual abstinence or vasectomized partner.
- •9.Women of childbearing potential or less than one year after menopause (unless surgically steril) must have a negative pregnancy test (urine ß-HCG) at screening. Pregnancy test has to be repeated at baseline in case of ab-sence of menstruation or irregular menstrual cycle.
- •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 385
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 115
排除标准
- •Exclusion criteria related to general health
- •1.Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration (a maximum of 32 weeks following baseline)
- •2.Functional class IV as identified by the ACR classification of Functional Status in Rheumatoid Arthritis.
- •3.Rheumatic autoimmune disease other than RA, including SLE, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty's syndrome). Sjögren's syndrome with RA is allowable.
- •4.Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, active Lyme disease).
- •Exclusion criteria related to medications
- •5.Patients currently participating in another clinical trial or patients who have participated in another clinical trial within 30 days prior to screening (or five half-lifes of the IMP, whichever is longer) or patients who participated in this trial before.
- •6.Previous treatment with any cell depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20).
- •7.Treatment with intravenous gamma globulin plasmapheresis or immunosorbent column (e.g. Prosorba®) within six months of base-line.
- •8.Intra-articular or parenteral corticosteroids within four weeks prior to baseline. Injection of intra-articular steroids while on study medication is discouraged, but may be used in a limited fashion.
- •9.Immunization with a live/attenuated vaccine within four weeks prior to baseline.
- •10.Previous treatment with TCZ, RTX, or other biologic DMARDs such as TNF-blockers.
- •11.Combination therapy with methotrexate (MTX) and leflunomide within 4 weeks prior to baseline.
- •12.Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.
- •Exclusion criteria related to general safety
- •13.Severe heart failure (NYHA class IV) or severe, uncontrolled cardiac diseases.
- •14.History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
- •15.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (incl. obstructive pulmonary disease), renal, hepatic, endocrine (incl. uncontrolled diabetes mellitus) or gastrointestinal disease.
- •16.Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
- •17.History of diverticulitis, diverticulosis requir-ing antibiotic treatment or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations or evidence of serious uncontrolled concomitant gastrointestinal disease.
- •18.Current liver disease as determined by principal investigator (patients with prior history of ALT elevation will not be excluded.)
- •19.Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, granulomatous disease on chest X-ray (X-ray should not be older than 90 days related to treatment start), Hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds), or any major episode of infection requiring
研究者
相似试验
招募中
1 期
Clinical efficacy and safety of sequential therapy with cryotherapy and topical tirbanibulin 1% in actinic keratoses in transplant recipients: a randomised clinical trial.MedDRA version: 20.0Level: PTClassification code: 10000614Term: Actinic keratosis Class: 100000004858Actinic keratosisCTIS2023-508091-11-00Clinica Universidad De Navarra40
招募中
2 期
Efficacy and safety study of a therapeutic regimen using Tamibarotene (Am80) and arsenic trioxide (ATO) in combination with Gemtuzumab Ozogamicin (GO) as a post-remission therapy for relapsed acute promyelocytic leukemia (APL)Relapsed acute promyelocytic leukemiaRelapsed acure promyelocytic leukemia, Tamibarotene, Arsenic trioxide, Gemtuzumab ozogamicinJPRN-jRCTs041190101Kiguchi Toru39
进行中（未招募）
不适用
Efficacy of short duration sequential therapy versus standard intravenous therapy for patients with uncomplicated catheter related bacteremia due to S. aureus methicillin-susceptible.on complicated Catheter related S. aureus meticillin sensible bacteremiaEUCTR2013-000511-24-ESFUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD
招募中
不适用
Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16)Adult T-cell leukemia-lymphomaJPRN-UMIN000022819Cooperative research with Fukuoka Blood & Marrow Transplant Group and CReS Kyushu30
招募中
不适用
Drug therapy of Helicobacter pylori infectioHelicobacter pylori infection.Helicobacter pylori [H.pylori] as the cause of diseases classified to other chaptersIRCT2017062234698N1Qazvin University of Medical Sciences120