Optimization of Treatment With Adalimumab (HUMIRA): A Multi-center, Randomized, Single Blind, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Change in Disease Activity as measured by the DAS28 after 12 months of treatment
研究概览
简要总结
The purpose of this trial is to assess the effect of two Intensive Outpatient Management Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid Arthritis (RA) that are treated with adalimumab.
This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial. A total of 300 patients (100 per group) with RA will be recruited from approximately 40 sites across Canada.
详细描述
Background:
Rheumatoid arthritis (RA) is chronic systemic inflammatory disease often leading to damage and disability (Lee DM, et al.). RA is associated with a shorter life expectancy (Pincus T, et al.) and, if untreated, can lead to significantly lower quality of life and functional impairment (Bradley EM, et al.).
The concept of tight control, involving the treatment of patients to specified targets with close monitoring and treatment adjustment when necessary, has been trialed in early RA. Many targeted studies have demonstrated improved outcomes or faster target achievement in early RA.
The TICORA trial, which studied a group of patients who had active disease but who had not progressed to multiple DMARDs or biologic therapy, demonstrated that the usage of an intensive outpatient management strategy (IOMS) of RA improved clinical outcomes measures (Grigor C, et al.). Indeed, the results from this clinical trial have shown that strict control and intense follow up, which are based on titration of treatment in accordance to a standardized protocol, improved disease activity, physical function and quality of life of patients without additional cost.
The proposed study will evaluate the application of two types of IOMS. The first IOMS will consist of titration of treatments based on the attainment of a DAS28 score under 2.4 (DAS28-IOMS). The second IOMS will consist of titration of treatment based on the attainment of zero swollen joints (0SJ-IOMS) (28 joints evaluated). Investigators should aim at achieving those targets within a reasonable period of time, i.e. during the first six months of treatment with adalimumab. In addition, investigators should aim at attaining these targets within reasonable limits for each individual patient. The clinical impact of these two IOMS will be compared to that of routine care (RC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a diagnosis of rheumatoid arthritis
- •Patient is > 18 years of age
- •Patient is naïve to HUMIRA® (adalimumab) therapy.
- •Patient has access to reimbursement for their standard of care.
- •If female, patient is either: 1) not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or 2) of childbearing potential and practicing one of the following methods of birth control:
- •condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- •contraceptives (oral or parenteral) for three months prior to enrollment in the study
- •a vasectomized partner
- •total abstinence from sexual intercourse
- •If female and of childbearing potential, patient must have a negative serum pregnancy test performed at Screening.
- •Patient is able to give written informed consent and to complete the survey requirements.
排除标准
- •Patients had a history of cancer within the past 5 years other than a successfully treated basal cell carcinoma and/or localized carcinoma in situ of the cervix
- •Patients with a history either of lymphoma or leukemia.
- •Patients with a history of untreated active tuberculosis, or listeriosis, or other currently active infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic protozoal or fungal infections.
- •Patients with a known positive HIV test.
- •Patients with a known positive HepBsAg test.
- •Patients with a persistent or severe infection(s) requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days, prior to enrollment.
- •Female patients who are breast-feeding.
- •Patients with clinically significant concurrent illness that in the investigator's judgment may influence the study outcomes (such as MS, moderate to severe CHF, etc,).
- •Patients with any condition that would prevent participation or completion in this study including language limitation or possibility that the patient will not be available for the complete study period (18 months).
结局指标
主要结局
Change in Disease Activity as measured by the DAS28 after 12 months of treatment
时间窗: Baseline (0) and Month 12
The change in DAS28 will be calculated as an absolute and percent value. The percent change in DAS28 will the calculated as \[DAS28M12 - DAS28M0) / (DAS28M0} x 100% where: DAS28M12 is the DAS28 score at 12 months and - DAS28M0 is the DAS28 score at baseline. The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).
次要结局
- Absolute and percent change in DAS28(Baseline (0), Month 6, Month 12 and Month 18 (Study end))
- Absolute and percent change in the Health Assessment Questionnaire (HAQ)(Baseline (0), Month 6, Month 12 and Month 18 (Study end))
- Absolute and percent change in individual components of the DAS28(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Percent achieving clinical remission defined as a DAS28 < 2.6(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Time to achieving clinical remission as measured by the DAS28 <2.6(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Percent achieving a DAS28 < 3.2(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Time to achieving a DAS28 <3.2(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Percent achieving a DAS28<2.4(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Time to achieving a DAS28<2.4(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Percentage achieving good or moderate European League Against Rheumatism (EULAR) responses(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Time to achieving good or moderate EULAR responses(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Patient Satisfaction with Care(Baseline (0), Month 6, Month 12, Month 18 (Study End))
- Absolute and percent change in the Work Limitations Questionnaire (WLQ)(Baseline (0), Month 6, Month 12 and Month 18 (Study end))
- Incidence of adverse events / serious adverse events(Baseline (0), Month 6, Month 12, Month 18 (Study End))
研究者
Janet Pope
Prinicipal Investigator
Lawson Health Research Institute