Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,662
- 主要终点
- Number of Participants With Serious Infections
研究概览
简要总结
Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period
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
- •At least 18 years of age, of either sex, and of any race.
- •Must have active or fistulizing CD and must have experienced at least 1 of the following:
- •failed a tapering regimen of corticosteroids and will be initiating immunosuppressive therapy
- •required corticosteroid treatments for the previous 6 months and will be initiating immunosuppressive therapy
- •luminal or fistulizing CD, which, in the treating physician's judgment, qualifies for initiation of Remicade.
- •Willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
- •Must be evaluated for active and inactive (latent) tuberculosis (TB) at the Baseline Visit. TB evaluation will consist of TB history questions (eg, medical history, possible previous contact with TB, TB vaccination history). TB evaluation and TB screening (eg, skin test, chest x-ray) are required when a subject starts treatment with Remicade. In these cases, subjects must be screened for TB within 3 months prior to initiating Remicade treatment.
排除标准
- •Female who is pregnant or nursing.
- •Treated with Remicade prior to Baseline.
- •Previously treated with other tumor necrosis factor (TNF)-active agents and other investigational drugs for CD prior to Baseline.
- •Active or untreated latent TB or other severe infections such as sepsis, abscesses, or opportunistic infections.
- •Moderate or severe heart failure (New York Heart Association [NYHA] Class III: subjects with marked limitation of activity; they are comfortable only at rest/Class IV: subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).
- •Have lymphoproliferative disorders (eg, lymphoma) or malignancies.
- •In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
- •Are participating in any other clinical trials (excluding registries).
- •In addition, subjects will be excluded from treatment with Remicade if any of the criteria listed below are met:
- •Females of childbearing potential unwilling to use a medically accepted method of birth control during treatment with Remicade and to continue its use for at least 6 months after the last Remicade treatment.
- •History of hypersensitivity to murine proteins or to any excipients of Remicade formulation (sucrose, polysorbate 80, monobasic sodium phosphate, and dibasic sodium phosphate).
- •Other conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC).
结局指标
主要结局
Number of Participants With Serious Infections
时间窗: Up to 5 Years
The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii \[PCP\] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.
Number of Participants With Infusion-Related Reactions/Hypersensitivity
时间窗: Up to 5 Years
The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.
Number of Participants With Demyelinating Neurological Disorders
时间窗: Up to 5 Years
The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.
Number of Participants With New or Worsening Congestive Heart Failure
时间窗: Up to 5 Years
The number of participants with new or worsening congestive heart failure was evaluated throughout the study.
Number of Participant Fatalities
时间窗: Up to 5 Years
The number of participant fatalities was evaluated throughout the study.
Number of Participants With Hematologic Conditions
时间窗: Up to 5 Years
The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.
Number of Participants With Lymphoproliferative Disorders/Malignancies
时间窗: Up to 5 Years
The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.
次要结局
- Participant Assessment of Overall Health Status By Study Visit(Up to 5 Years)
- Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months(Up to 5 Years)
- Work/Daily Activity Status Score By Study Visit(Up to 5 Years)
- The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit(Up to 5 Years)
- Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months(Up to 5 Years)
- Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months(Up to 5 Years)
- Number of Participants With a Draining Fistula By Study Visit(Up to 5 Years)