ACTRN12620000827932已完成未知
A phase 4, longitudinal, single-arm, open-label treatment study of subcutaneous golimumab effectiveness assessed by both speed of magnetic resonance imaging (MRI) changes in the hand/wrist and clinical response outcomes in patients with rheumatoid arthritis.
Emeritus Research Pty Ltd0 个研究点目标入组 18 人开始时间: 2020年8月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1Male or female adult participants greater than or equal to 18years of age who can give informed consent, able to understand English and willing and able to complete the study activities.
- •2Clinically defined active rheumatoid arthritis despite Methotrexate use (plus or minus other DMARDs), where active rheumatoid arthritis is defined as a DAS28-CRP equals 4.2 at screening.
- •3Clinically active synovitis of the chosen hand or wrist on MRI at screening, as determined by the MRI reader.
- •4The Methotrexate dose must be less than or equal to 25mg per week and the participant must also be on folic acid supplement according to local standard of care. The Methotrexate dose must have been stable for 3 months prior to baseline.
- •5If the participant is on a DMARD in addition to Methotrexate at the time of screening (allowed but not required), the dose must have been stable for 3 months prior to baseline.
- •6Non-steroidal anti-inflammatory drug (NSAID) medications are allowed but the participant is not required to be using these medications. If NSAIDs are being taken at the time of screening, the dose must have been stable for 10 days prior to baseline.
- •7Prednisolone is allowed but the participant is not required to be using this medication. If prednisolone is being taken at the time of screening, the dose must be less than or equal to 10mg per day and the dose must have been stable for 2 weeks prior to baseline.
排除标准
- •1.Negative (i.e. no signs of active clinical synovitis) MRI of the chosen hand/wrist at screen as determined by the central MRI reader.
- •2.Inability to have MRI due to either claustrophobia or other contraindications to MRI.
- •3.Contraindication to use of golimumab (such as active tuberculises or other severe infections; opportunistic infections; concurrent use of golimumab with anakinra or abatacept; hypersensitivity to the active substance or any of the excipients; risk of Hepatitis B reactivation [i.e. surface antigen positive]; congestive heart failure; demyelinating disorders).
- •4. No pregnant or breastfeeding; willing to use contraception
- •5.Previous biologic use of any class.
- •6.Previous use of a JAK inhibitor.
- •7.Active Tuberculosis (TB) as determined by local Quanti-FERON gold and local chest x-ray. If latent TB is diagnosed, the participant may be enrolled into the study providing treatment for latent TB according to local standard of care is initiated prior to the first dose of golimumab. If results are available from a chest x-ray and/or QuantiFERON gold within the three months prior to baseline, there is no need to repeat and these results can be used to assess eligibility.
- •8.Recent infection requiring intravenous antibiotics in the previous three months.
- •9.Moderate to severe, uncontrolled, heart failure.
- •10.Positive Hepatitis B, Hepatitis C or HIV laboratory tests. If results are available from Hepatitis B, Hepatitis C or HIV laboratory tests within the three months prior to baseline, there is no need to repeat and these results can be used to assess eligibility.
- •11.Malignancy in the previous 5 years. Adequately treated Squamous cell carcinoma, basal cell carcinoma and carcinoma in situ of the cervix are acceptable.
- •12.History of demyelinating disorders, including multiple sclerosis.
- •13.Live vaccines in the previous three months or plans to receive a live vaccine while on study (inactivated vaccines are acceptable).
- •14.Latex allergy or if the participant has a latex allergy, no caregiver who is able to give the golimumab injections.
研究者
相似试验
进行中（未招募）
4 期
A clinical trial to study effects of Teriparatide in the Treatment of Postmenopausal Osteoporosis.CTRI/2023/05/052618Enzene Biosciences Limited
进行中（未招募）
1 期
Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Patients With Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Plaque PsoriasisEUCTR2020-004061-39-SEJanssen-Cilag International NV50
进行中（未招募）
1 期
Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Patients With Moderate to Severe Plaque PsoriasisPlaque PsoriasisEUCTR2020-004061-39-DEJanssen-Cilag International NV50
进行中（未招募）
1 期
Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Patients With Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Plaque PsoriasisEUCTR2020-004061-39-GRJanssen-Cilag International NV50
进行中（未招募）
1 期
Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Patients With Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Plaque PsoriasisEUCTR2020-004061-39-ITJANSSEN CILAG INTERNATIONAL NV50