EUCTR2007-002066-35-SK进行中（未招募）1 期
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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)Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study.
- •2)Subjects must be at least 18 years of age.
- •3)If the subject is a sexually active woman of childbearing potential, she and any male partner are required to simultaneously use 2 effective contraceptive methods, from the list of effective contraceptives found in Section 4.4.2
- •4)Non vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an IUD, barrier method with spermicide, oral contraceptive, injectable progesterone, sub dermal implant, or a tubal ligation, if the woman could become pregnant from the time of the first dose of study medication until completion of follow up procedures.
- •5)The subject has a diagnosis of RA based upon the American College of Rheumatology (ACR; formerly American Rheumatism Association) 1987 Revised Criteria,5 ie, fulfilling at least 4 of the following 7 criteria for at least 6 consecutive months preceding randomization:
- •a.morning stiffness in and around any joint for more than 1 hour;
- •b.soft tissue swelling of 3 or more joint areas;
- •c.swelling of the proximal interphalangeal (PIP), metacarpophalangeal (MCP) or wrist joints;
- •d.symmetrical joint swelling;
- •e.rheumatoid nodules;
- •f.serum rheumatoid factor positive;
- •g.radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.
- •6)The subject has active disease at both Screening and Baseline, as defined by both:
- •a.=6 joints tender or painful on motion, AND
- •b.=6 joints swollen;
- •and fulfills 1 of the following 2 criteria at Screening:
- •i.Erythrocyte sedimentation rate (ESR) (Westergren method) above the upper limit of normal in the local laboratory
- •ii.C reactive protein (CRP) >7 mg/L in the central laboratory
- •7)The subject meets ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III (Appendix 1).
- •8)Subjects receiving non prohibited concomitant medications for any reason must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to first study dose, or as defined in Concomitant Medications (Section 5.5).
- •9)Subjects must have failed an adequate study of therapy with at least 1 DMARD due to lack of efficacy or toxicity. See inclusion criteria 10 and exclusion criteria 1 and 12.
- •10)Subjects having received the following treatment regimens are eligible, provided the following discontinuation periods are observed. Note that none of these therapies should be discontinued by a subject to allow participation in this study if they are currently effective and tolerated.
- •a.Within 4 weeks of first dose of study drug:
- •leflunomide (Arava® ) (see additional washout information for leflunomide in Appendix 10), methotrexate, sulfasalazine, and d penicillamine, minocycline; etanercept (Enbrel®); anakinra (Kineret®);
- •Immunosuppressive/Immunomodulatory therapies azathioprine, cyclosporine, and PROSORBA® device/column;
- •NSAIDs any experimental NSAIDs or experimental selective COX 2 inhibitors;
- •Other herbal medications, immunization with any live virus vaccination (eg, FluMist™) other than oral polio vaccine , intra articular, intramuscular, or intravenous corticosteroids;
- •b.Within 8 weeks of first dose:
- •infliximab (Remicade®), aur
排除标准
- •1)Subjects who discontinued any previous TNFi therapy. Subjects who previously received adalimumab therapy are not allowed in the study.
- •2)Subjects with evidence of hematopoietic disorders:
- •a.Hemoglobin levels <9.0 gm/dL or hematocrit <30% at screening visit or within the 3 months prior to first study dose.
- •b.An absolute white blood cell (WBC) count of <3.0 x 109/L or absolute neutrophil count of <1.2 X 109/L at screening visit or within the 3 months prior to first study dose.
- •c.Thrombocytopenia at screening visit or within the 3 months prior to first study dose.
- •3)Estimated GFR =50 ml/min based on Cockcroft Gault calculation
- •4)Pregnant or lactating women.
- •5)Total bilirubin, AST or ALT more than 2 times the upper limit of normal at screening visit.
- •6)Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- •Note that for the purposes of this protocol New York Heart Association Class III and Class IV Congestive Heart failure will both be considered severe.
- •7)History of an infected joint prosthesis at any time, with the prosthesis still in situ.
- •8)Current routine household contact with individuals who have received either varicella or FluMist® (within 4 weeks) or oral polio vaccine (within 8 weeks), prior to first study dose.
- •9)History of any lymphoproliferative disorder, history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
- •10)Evidence of active or latent infection with Mycobacterium tuberculosis (TB), as defined by any of the following:
- •a.A subject has a positive Mantoux Purified Protein Derivative (PPD) skin test within the 3 months prior to screening, OR
- •b.A subject is immunoreactive for TB using an ex vivo method, OR
- •c.A subject has a chest radiograph (taken within the 3 months prior to screening) that has changes suggestive of active TB infection.
- •If a subject has a positive PPD or is immunoreactive for TB using an ex vivo method, (s)he may be eligible if (s)he has completed an appropriate treatment regimen for TB and has a chest radiograph within the 3 months prior to Screening that has no evidence of active TB. A subject who is currently being treated for TB infection can only be enrolled with prior approval by the Sponsor.
- •11)Subjects with clinically significant infections currently or within 6 months of first dose of study drug (eg, those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), or those with a history of more than one episode of herpes simplex or zoster, a history of disseminated zoster, a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study or any infection requiring antimicrobial therapy within 2 weeks of screening.
- •12)Any prior treatment with lymphocyte depleting agents/therapies (such as CamPath®[alemtuzab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc). Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to first dose
- •13)Subjects with any condition possibly affecting oral drug absorption, gastrectomy, or clinically significant diabetic gastroenteropathy.
- •14)History of alcohol or drug abuse with less tha
研究者
相似试验
进行中（未招募）
1 期
A Safety, Efficacy and Pharmacokinetic Study in Adult Patients with Moderate to Severe Atopic DermatitisModerate to Severe Atopic DermatitisMedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2018-001544-64-GBRegeneron Pharmaceuticals, Inc.300
进行中（未招募）
1 期
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid ArthritisEUCTR2007-002066-35-BGPfizer Inc, 235 East 42nd Street, New York, NY 10017350
进行中（未招募）
不适用
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicableMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid ArthritisEUCTR2007-002066-35-HUPfizer Inc, 235 East 42nd Street, New York, NY 10017350
进行中（未招募）
1 期
A Safety, Efficacy and Pharmacokinetic Study in Adult Patients with Moderate to Severe Atopic DermatitisModerate to Severe Atopic DermatitisMedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2018-001544-64-ESRegeneron Pharmaceuticals, Inc.300
进行中（未招募）
1 期
A Safety, Efficacy and Pharmacokinetic Study in Adult Patients with Moderate to Severe Atopic DermatitisEUCTR2018-001544-64-DERegeneron Pharmaceuticals, Inc.300