CTRI/2025/12/098446尚未招募Unknown
A prospective multicentre open label phase IV study to evaluate safety efficacy immunogenicity profile of UstekiRel in Plaque Psoriasis, Psoriatic Arthritis, Ulcerative Colitis and Crohn's Disease
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 17
研究概览
简要总结
This is prospective, multi-centre, open label, phase IV study to evaluate safety efficacy & immunogenicity profile of UstekiRel® in approved indications. In this study, a total of 240 patients with 60 patients with moderate to severe plaque psoriasis, 60 patients with moderate to severe psoriatic arthritis and 120 patients with inflammatory bowel disease (80 patients with moderate to severe ulcerative colitis and 40 patients with moderate to severe Crohn’s disease) will be enrolled to ensure 216 evaluable patients (considering a drop-out rate of 10%).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female between 18 and 65 years of age inclusive Women of childbearing potential and all men must be using adequate birth control measures eg abstinence oral contraceptives intrauterine device barrier method with spermicide or surgical sterilization and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study drug Able to adhere to the study visit schedule and other protocol requirements Capable of giving informed consent and the consent must be obtained prior to any study related procedures Must agree to avoid prolonged sun exposure and other ultraviolet light sources during study Must have screening laboratory test results within acceptable limits as defined below a Hemoglobin more than or equal to 10 g per dL b White blood cells more than or equal to 35 x 109 per L c Neutrophils more than or equal to 15 x 109 per L d Platelets more than or equal to 100 x 109 per L e Serum creatinine less than or equal to 15 mg per dL f AST and ALT less than or equal to 2 times the upper limit of normal g Alkaline phosphatase levels less than or equal to 2 times the upper limit of normal Patients must be considered eligible according to the following TB screening criteria a Have no history of latent or active TB prior to screening b Have no signs or symptoms suggestive of active TB upon medical history and or physical examination c Have had no recent close contact with a person with active TB or if there has been such contact patient should undergo thorough evaluation for TB prior to study enrolment d Have no evidence of latent TB based on tuberculin skin Mantoux test QuantiFERON TB Gold test or other tuberculosis screening tests performed during screening e Have no evidence of current active TB or old inactive TB based on chest radiograph Plaque psoriasis a Patients with diagnosis of plaque type psoriasis at least 6 months prior to first administration of study drug b Patients with moderate to severe plaque psoriasis with more than or equal to 10 percentage BSA involvement and PASI score more than or equal to 12 at screening c Patients who are potential candidates for phototherapy or systemic treatment of psoriasis d Failed to respond to or have a contraindication to or are intolerant to other systemic therapies including ciclosporin methotrexate or PUVA psoralen and ultraviolet A Psoriatic arthritis a Active psoriatic arthritis more than or equal to 3 swollen joints and more than or equal to 3 tender joints in at least one of the following forms 1 distal interphalangeal DIP involvement 2 polyarticular arthritis absence of rheumatoid nodules and presence of psoriasis three arthritis mutilans asymmetric psoriatic arthritis or 5 spondylitis like ankylosis b Patients with plaque psoriasis with a lesion more than or equal to 2 cm in diameter Ulcerative Colitis a Has moderately to severely active UC defined as a Baseline Week 0 Mayo score of 6 to 12 including a screening endoscopy subscore of the Mayo score greater than or equal to more than or equal to 2 as determined by a central reading of the video endoscopy c Has a clinical diagnosis of Ulcerative Colitis UC at least 3 months before screening Crohns Disease d Patients with confirmed diagnosis of Crohns disease since at least 6 months and eligible to be administered infliximab as per prescribing information of infliximab innovator a Patients with moderate to severe active Crohn s disease defined as a Crohn s Disease Activity Index CDAI score of at least 220.
排除标准
- •1 Patients with nonplaque forms of psoriasis eg erythrodermatic guttate or pustular 2 Patients with current druginduced psoriasis eg a new onset of psoriasis or an exacerbation of psoriasis from beta blockers calcium channel blockers or lithium 3 Pregnant nursing females or planning pregnancy both males and females during the study period until 12 months after receiving the last injection of study drug 4 Use of any therapeutic agent targeted at reducing lL12 or IL23 including but not limited to Ustekinumab 5 Patients who have received phototherapy or any systemic medications or treatments that could affect psoriasis or PASI evaluation including but not limited to oral or injectable corticosteroids retinoids 125 dihydroxy vitamin D3 and analogues psoralens sulfasalazine hydroxyurea or fumaric acid derivatives within 4 weeks prior to first administration of study drug 6 Use of topical medications or treatments that could affect psoriasis or PASI evaluation eg corticosteroids anthralin calcipotriene topical vitamin D derivatives retinoids tazarotene methoxsalen trimethylpsoralens within 2 weeks prior to first administration of study drug 7 Use of any systemic immunosuppressants eg methotrexate azathioprine cyclosporine 6thioguanine mercaptopurine mycophenolate mofetil hydroxyurea and tacrolimus within 4 weeks prior to first administration of study drug 8 Use of any biologic within the previous 3 months or 5 times the halflife of the biologic whichever is longer prior to first administration of study drug 9 Patients who have received lithium or antimalarials within 4 weeks prior to first administration of study drug 10 Patients who have received a live virus or bacterial vaccination within 3 months prior to screening Subjects must agree not to receive a live virus or bacterial vaccination during the study and up to 12 months after the last dose of study drug 11 Patients who have received a BCG vaccination within 12 months prior to screening Subject must agree not to receive a BCG vaccination during the study or up to 12 months after the last dose of study drug 12 History of chronic or recurrent infectious disease including but not limited to chronic renal infection chronic chest infection eg bronchiectasis recurrent urinary tract infection recurrent pyelonephritis or chronic nonremitting cystitis or open draining or infected skin wounds or ulcers 13 History or current evidence of a serious infection eg sepsis pneumonia or pyelonephritis within 2 months prior to screening or have been hospitalized or received IV antibiotics for an infection within 2 months prior to screening 14 History of latent or active granulomatous infection including TB histoplasmosis or coccidioidomycosis prior to screening 15 History or current evidence of a nontuberculous mycobacterial infection or opportunistic infection eg cytomegalovirus Pneumocystis carinii aspergillosis 16 History of a herpes zoster infection within 2 months prior to first administration of study drug 17 Positive HIV HBsAg or HCV test at screening 18 Current signs or symptoms of severe progressive or uncontrolled renal hepatic hematological gastrointestinal endocrine pulmonary cardiac neurologic cerebral or psychiatric disease 19 History of lymphoproliferative disease including lymphoma or signs and symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy and/or splenomegaly 20 Known history of malignancy 21 History of hypersensitivity to ustekinumab any of the excipients latex sensitivity or any immunoglobulin product eg plasma derived or recombinant monoclonal antibody 22 History of substance abuse drug or alcohol within 12 months prior to screening 23 Participation in any clinical study of an investigational product within 3 months prior to first administration of study drug 24 Has severe extensive colitis and is at imminent risk of colectomy for inflammatory bowel disease group 25 Has UC limited to the rectum only or to less than or equal to 20 centimeters cm of the colon for inflammatory bowel disease group 26 Presence of a stoma or history of a fistula for inflammatory bowel disease group 27 Participants with history of extensive colonic resection for example less than 30 cm of colon remaining that would prevent adequate evaluation of the effect of study agent on clinical disease activity for inflammatory bowel disease group 28 Has complications of Crohns disease such as symptomatic strictures or stenoses short gut syndrome or any other manifestation that might be anticipated to require surgery for inflammatory bowel disease group.
研究者
Dr Ajaykumar Yadav
Reliance Life Sciences
研究点 (17)
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