EUCTR2016-000064-42-BGActive, not recruitingPhase 1
Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Merck KGaA
- Enrollment
- 65
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Men or women 18 to 75 years of age at the time of informed consent signature
- •Confirmed diagnosis of RA according to 2010 American College of Rheumatology (ACR)/The European League Against Rheumatism (EULAR) RA classification criteria of at least 6 months duration
- •Positive RF and/or anti-CCP (anti-cyclic citrullinated peptide)
- •Persistently active disease defined as = 6 swollen joints (of 66 counted) and = 6 tender joints (of 68 counted)
- •hsCRP = 3.6 mg/L
- •Treatment for = 12 weeks with 10 to 25 mg/week MTX at a stable dose for at least 4 weeks prior to dosing with the IMP and maintained throughout the trial
- •Women of childbearing potential must use a highly effective method of contraception combined with one supplementary barrier method for 4 weeks prior to randomization, throughout the trial, and for 90 days after the last dose of IMP. For the purposes of this trial:
- •o Females who are postmenopausal (age-related amenorrhea = 12 consecutive months and increased follicle-stimulating hormone [FSH] > 40 mIU/mL), or who have undergone hysterectomy or bilateral oophorectomy are exempt from pregnancy testing. If necessary to confirm postmenopausal status, an FSH will be drawn at Screening
- •oThe definition of highly effective contraception includes:
- •-combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal
- •-progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, implantable
- •-intrauterine device (IUD)
- •-intrauterine hormone-releasing system (IUS)
- •-bilateral tubal occlusion
- •-vasectomized partner
- •-sexual abstinence
- •oSupplementary barrier methods include:
- •-male or female condom with or without spermicide
- •-cap, diaphragm or sponge with spermicide
- •Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Day 1/randomization before dosing.
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
Exclusion Criteria
- •Use of oral corticosteroids > 10 mg daily prednisone equivalent, use of injectable corticosteroids, or change in dose of corticosteroids within 2 weeks prior to Screening or during Screening
- •Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to Screening
- •Treatment with tofacitinib, other BTK inhibitors, or a biologic disease-modifying antirheumatic drug (DMARD; eg, anti-tumor necrosis factor alpha [anti-TNF-a], tocilizumab [anti-interleukin-6 receptor], abatacept [CTLA4-Fc]), or other immunosuppressive drugs(sulfasalazine would be acceptable at a stable dose) other than methotrexate within 3 months prior to Screening or during Screening
- •Treatment with anti-CD20 therapy (eg, rituximab) within 12 months prior to Screening or during Screening
- •Immunologic disorder other than RA, with the exception of secondary Sjogren’s syndrome associated with RA, and well-controlled diabetes or thyroid disorder, or any other condition requiring oral, intravenous, intramuscular, or intra-articular corticosteroid therapy
- •Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
- •Active, clinically significant, viral, bacterial, or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of Screening or during Screening, or completion of oral anti-infectives within 2 weeks before or during Screening, or a history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary.
- •History of or positive testing for human immunodeficiency virus (HIV), hepatitis C antibody and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg) (+) and/or hepatitis B core total, and/or IgM antibody (+) at Screening.
- •History of or current diagnosis of active tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of the Screening Visit of a positive TB skin test with purified protein derivative with induration = 5 mm, a positive QuantiFERON®-TB test or positive or borderline T-SPOT [Elispot] test); or positive QuantiFERON-TB test at Screening. Subjects with documented completed appropriate LTBI treatment would not be excluded and are not required to be tested.
- •Subjects with current household contacts with active TB will also be excluded.
- •Indeterminate QuantiFERON-TB or T-SPOT tests may be repeated once, and will be considered positive if retest results are positive or indeterminate.
- •History of cancer, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix, unless considered cured > 5 years.
- •Clinically significant abnormality on ECG, or an active infective process or any other clinically significant abnormality on Screening chest X-ray (CXR) taken within 4 weeks of the first dose, per Investigator opinion. If a CXR has been taken within th
Investigators
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