EUCTR2011-002067-20-CZ进行中（未招募）1 期
A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. -
CB Pharma SA0 个研究点目标入组 892 人开始时间: 2012年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 892
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. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
- •2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator.
- •3. Subject is =18 years of age at Screening.
- •4. Subject must have a diagnosis of RA at Screening, as defined by the 2010 EULAR/ACR classification criteria (Aletaha D et al, 2010).
- •5. Subject must have a positive rheumatoid factor (RF) and/or a positive anti cyclic citrullinated peptide antibody (anti-CCP) as determined by the central
- •laboratory at Screening.
- •6. Subject must have moderate to severe RA disease at Screening and Baseline defined
- •as: a) Screening (all criteria required): i. =4 swollen joints (of 28
- •prespecified joints). ii. DAS28(ESR) >3.2. iii. CRP concentration =
- •10mg/L (or 1.0mg/dL) and/or ESR (Westergren) =28mm/hr. b)
- •Baseline (both criteria required): i. =4 swollen joints (of 28 prespecified
- •joints). ii. DAS28(ESR) >3.2. 7. Subject is considered by the Investigator
- •to be responding inadequately to treatment with MTX. An inadequate
- •response to MTX is based on the opinion of the Investigator and
- •following a minimum 12-week course of MTX therapy prior to the
- •Screening Visit. 8. Subject is using MTX 15 to 25mg/week orally or
- •subcutaneously at Screening and has used the same MTX regimen (dose
- •and route) for a minimum of 28 days prior to Baseline 9. If using oral
- •corticosteroids at Baseline, the subject is using a stable dose of =10mg
- •(unchanged for at least 28 days prior to Baseline). However, when deemed clinically necessary, 1 dose adjustment
- •of no more than ±2.5mg during the 28 days prior to Baseline is
- •acceptable provided the total dose does not exceed 10mg. 10. The
- •subject, if female, must be either postmenopausal for at least 1 year,
- •surgically sterile, or practicing an acceptable method of contraception,
- •such as: a. oral / parenteral / implantable hormonal contraceptives,
- •intrauterine device, or barrier and spermicide. b. Subjects must agree to
- •use adequate forms of contraception from Screening through at least 10
- •weeks (or longer if required by local regulations as reflected by local
- •product labelling) after the final dose of IMP. c. Male subjects must
- •agree to ensure they or their female partner(s) use adequate
- •contraception from Screening through at least 10 weeks (or longer if
- •required by local regulations as reflected by local product labelling) after
- •the final dose of IMP. Note: Abstinence is not an acceptable method of
- •contraception; therefore, subjects engaging or intending to engage in
- •sexual activity must agree to employ 1 of the aforementioned acceptable
- •methods of contraception. 11 Subject must have completed the Washout Periods for analgesics and
- •nonbiologic DMARDs (except MTX) in accordance with Table 6.1 of the
- •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 446
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 446
排除标准
- •1. Subject has previously participated in this study (except when
- •rescreening criteria apply) or subject (sbj) has received treatment with
- •any biologic DMARD or has received treatment with
- •cyclophosphamide,chlorambucil,Janus kinase,spleen tyrosine kinase or
- •phosphodiesterase 4 inhibitors or investigational agents such as spleen
- •tyrosine kinase. 2. Sbj was randomized in another study of medication or
- •a med. device within the previous 3 months or is currently participating in another study of a medication or med. device under investigation
- •[Criterion 3-4-5-6: please refer to the protocol – not modified by this
- •amendment] 7. Sbj must not have a diagnosis of any other inflammatory
- •arthritis (eg psoriatic arthritis, ankylosing spondylitis or systemic lupus
- •erythematosus/lupus nephritis) or have a Steinbrocker IV functional
- •capacity. Sbj with Sjogren's Syndrome, as assessed by the PI to be
- •limited to mild or moderate sicca symptoms that are considered to be a
- •manifestation of secondary Sjogren's Syndrome related to RA, may be
- •enrolled. However, systemic manifestations attributable to primary
- •Sjogren's Syndrome are still considered exclusionary 8. Sbj must not
- •have received any experimental biological or nonbiological therapy for
- •immuno inflammatory indications 9. The subject may not use prohibited
- •medications and may only use (if needed) medications within protocol
- •defined limitations as outlined in IC 11 and Table 6.1 10. Sbj with active
- •malignancy or a history of cancer. Exceptions are subjects with: no more
- •than 2 basal cell carcinomas excised prior to study entry - cervical
- •carcinoma in situ successfully surgically treated more than 5 yrs prior to
- •Screening 11. Sbj with a history of a lymphoproliferative disorder
- •including lymphoma or signs and symptoms suggestive of
- •lymphoproliferative disease 12. Sbj with a history of blood dyscrasias 13.
- •Sbj with a recent history or existing condition, as determined by the PI,
- •of severe, progressive, and/or uncontrolled renal, hepatic,
- •hematological, gastrointestinal, endocrine, pulmonary, cardiac,
- •neurological, or cerebral disease or other significant
- •immunological/inflammatory disease including but not limited to
- •inflammatory bowel disease [Criterion 14-15-16-17-18-19: please refer
- •to the protocol - not modified by this amendment] 20. Sbj with a history
- •or active systemic/respiratory infection due to fungal, parasitic, or
- •mycotic pathogens including but not limited to histoplasmosis,
- •coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus and
- •nontuberculus mycobacteria. Radiographic findings suggestive of
- •infections such as apical fibrosis, pleural thickening, pulmonary nodules
- •(including any pulmonary nodules of unspecified significance), fibrotic
- •scars, calcified granulomas, upper lobe infiltrates, cavitations and
- •pleural effusions, calcified lung nodules, calcified hilar lymph nodes, and
- •pericardial calcification or any other finding that could be suggestive of
- •inactive TB or active TB, are sufficient grounds for exclusion.
- •Radiographs will be assessed by a radiologist whose review of the
- •radiograph includes a deliberate assessment of the presence or absence
- •of TB infection, granulomatous disease, etc. Any abnormal radiographic
- •findings should be discussed with the Sponsor and/or Medical Monitor
- •prior to subject enrollment 21. Sbj with a history of chronic or recurrent
- •infections such as: - more than 3 episodes requiring antibiotics or
研究者
相似试验
进行中（未招募）
1 期
Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.Moderate to severe rheumatoid arthritisMedDRA version: 18.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859EUCTR2011-002067-20-DECB Pharma SA915
进行中（未招募）
不适用
Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.Moderate to severe rheumatoid arthritisMedDRA version: 14.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859EUCTR2011-002067-20-GRCB Pharma SA892
进行中（未招募）
不适用
Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.EUCTR2011-002067-20-ATCB Pharma SA892
进行中（未招募）
1 期
Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.Moderate to severe rheumatoid arthritisMedDRA version: 17.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859EUCTR2011-002067-20-PTCB Pharma SA892
进行中（未招募）
不适用
Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.EUCTR2011-002067-20-FRCB Pharma SA892