EUCTR2007-006129-29-NL进行中（未招募）不适用
A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MorphoSys AG
- 入组人数
- 89
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. Outpatients > 18 years of age
- •2. BMI between 19.0 and 35.0 kg/m2 (extremes included).
- •3. Diagnosis of rheumatoid arthritis (RA), according to the revised criteria of the American College of Rheumatology (ACR), 1987.
- •4. Active disease at screening defined as:
- •- At least 3 swollen and 3 tender joints with at least 1 swollen joint involvement of the hand excluding the proximal interphalangeal (PIP) joint (using the DAS28 joint count).
- •- Elevated CRP level > 5 mg/l (in RF and anti-CCP sero-negative patients) or > 2 mg/l (in RF and/or anti-CCP sero-positive patients).
- •- disease activity score DAS28 5. Functional status class I-III classified according to ACR 1991 revised criteria.
- •6. Concomitant use of the following RA treatments is allowed:
- •- NSAIDs (with a stable dosage for at least 2 weeks prior to randomization)
- •- Oral corticosteroids (maximum of 10 mg of prednisolone or equivalent per day with a stable dosage for at least 4 weeks prior to randomization)
- •- DMARDS: Concomitant DMARD treatment for at least 3 months with stable dosage for at least 4 weeks prior to randomization. Allowable treatments include:
- •Methotrexate (maximum of 25 mg/week) either oral, s.c., or i.v. Change of the administered formulation is allowed but not within 4 weeks prior to randomization.
- •Leflunomide (maximum 20 mg/day)
- •Antimalarials (hydroxychloroquine: maximum 400 mg/day, chloroquine: maximum 500 mg/day, quinacrine [mepacrine]: maximum 100 mg/day, compounded antimalarial drugs in which no individual component exceeds the maximum dose mentioned)
- •Sulfasalazine (maximum: 3 g/day)
- •A combination of any two of these DMARDs. Combination of methotrexate and leflunomide is not allowed due to liver toxicity.
- •7. Male patients must be willing to use an effective contraception method during the study and for at least 2 months following the completion/discontinuation of the study.
- •8. Negative purified protein derivative (PPD) tuberculin skin test reaction or a negative tuberculosis enzyme-linked immuno sorbent assay (ELISA) test, according to the local standard practices.
- •9. Possibility to evaluate pulmonary status for (latent) tuberculosis or other pulmonary infections by a chest x-ray not older than 3 month prior to screening.
- •10. Provide written informed consent and be able to comply with the patient’s assessment questionnaires.
- •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 89
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 89
排除标准
- •1. Previous treatment with immunosuppressive agents and non-compliance with min wash-out periods
- •required prior to first dosing of study drug: 1m for etanercerpt, anakinra, ciclosporin, MMF, tacrolimus; 2m for adalimumab and certolizumab and 3m for infliximab, abatacept, golimumab and tocilizumab
- •2. Previous treatment with rituximab within 9m prior to first dose of study drug
- •3. History of therapy with cell depleting agent(s) incl. IMPs (Campath, anti-CD3, -CD4, -CD5, -CD11a, -CD19, -CD22, -Blys/BAFF)
- •4. Any therapy with human, chimeric or murine Abs (except for above) or any experimental therapy within 3m or 5 half-lives (whichever is longer) prior to screening
- •5. In case patient has been discontinued from other DMARDs due to toxicity or lack of efficacy, time since last dose at least 1m and effects of that agent should have dissipated as indicated by recognized duration of effect (e.g. hydroxychloroquine, sulfasalazine), or standard wash-out procedure (cholestyramine for leflunomide)
- •6. Patients who received systemic steroids, epidural steroid injections, intra-articular or systemic corticosteroid injections within 4w before screening
- •7. Known allergy to murine, chimeric or human antibodies
- •8. Body weight >150 kg
- •9. History of anaphylaxis/severe anaphylactic reaction/shock to any drug administered parentarally & suspected allergies to protein based therapeutics. In all other cases, subjects should be pre-treated with anti-histamines and H-1 receptor inhibitors
- •10. Pregnant/breast-feeding women & pre-menopausal women not receiving methotrexate or leflunomide a/o not willing to use at least 2 methods of effective contraception during and for a specific period after studyparticipation
- •11. Any findings indicative of tuberculosis or history of tuberculosis or a positive PPD- or tuberculosis ELISA test at screening
- •12. Presence or history of major chronic inflammatory autoimmune diseases
- •13. Positive hepatitis B surface antigen (HBs-Ag)test, hepatitis C (anti HCV antibody) test a/o confirmed HIV infection
- •14. Any type of infection requiring use of antibiotics & which does not resolve completely within 3w before sudy drug administration
- •15. History of recurrent pulmonary infections , recurrent abscesses, intra-abdominal infections or chronic infections
- •16. Procalcitonin serum level >0.5 ng/ml at screening
- •17. IgG level below lower limit of reference range at screening
- •18. History of reactivation of Epstein Barr (EB) viral infection or >1,000 EBV genome equivalent/10E6 cells in peripheral blood mononuclear cell preparations
- •19. History of malignancy with exception of basal cell/squamous cell carcinoma of skin/carcinoma of cervix
- •successfully treated within the last 3y
- •20.Significant cardiac disease on ECG
- •21. History of severe pulmonary disease
- •22. WBC <3.0x10E9/l, neutrophils <1.5x10E9/l, haemoglobin <10.0 g/dl, hematocrit <30%, platelets
- •<100x10E9/l or absolute lymphocyte count 23. Any signs of excretory hepatic (tot bilirubin >/= 1.5xULN) or renal insufficiency (creatinine clr/EGFR
- •<50ml/min) at screening.
- •24. Abnormal AST or ALT levels, i.e., >2x upper limit of reference range at screening
- •25. Live vaccines within 8w of study drug administration
- •26. Presence of contra-indications to MRI or contrast agents
- •27. Any condition/laboratory findings/medical history/pre-study assessments, that in the opinion of the
- •investigator constitute a risk or a contra-indication for the patient'
研究者
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