A Study Comparing MabionCD20 (new Rituximab biosimilar) with MabThera (reference Rituximab from EU) and Rituxan (reference Rituximab from US) in Patients with Rheumatoid Arthritis
- Conditions
- Moderate-to-severe rheumatoid arthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2020-002765-34-BE
- Lead Sponsor
- Mabion S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
1.Patients must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
2.Body Surface Area (BSA) between 1.5 and 2.2 m2, calculated according to the DuBois and DuBois formula: BSA in m2 = (weight (Kg)0.425 * height (cm) 0.725) * 0.007184).
3.Patients with confirmed rheumatoid arthritis, diagnosed according to the revised (2010) ACR/EULAR classification criteria, with a disease duration minimum of 6 months prior to the Screening Visit.
4.Patients with currently moderate to severe disease activity despite ongoing administration of an adequate methotrexate regimen. Moderate-to-severe activity is defined here as the presence of the following two
criteria:
a.Six or more swollen joints and =6 tender/painful joints (based on 66/68 joint count, not including distal interphalangeal joints), verified by a physician during screening and re-confirmed at baseline visit (Day 1).
b.DAS28-ESR score =3.2 at screening.
5.No history of treatment with TNF-a inhibitors (innovative or biosimilar, authorized or investigational) at any time before the screening i.e. patients naïve to TNF-a inhibitors.
6. Male or female.
7. Male patients must agree to use highly effective contraception, as detailed in Section 10.1. of this protocol, from the Screening Visit, during the intervention period, and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.
8.Female patients are eligible to participate if not pregnant, not breastfeeding, and at least one of the following
conditions applies:
•Not a woman of childbearing potential (WOCBP)
•Patient is a WOCBP, but she and her partner agree to follow the contraceptive guidance outlined in Section 10.1 from the Screening Visit, during the intervention period, and for at least 12 months after the last dose of the study intervention.
9.Able to provide written informed consent as described in Appendix 2: Regulatory, Ethical, and Study Oversight Considerations after receiving information about benefits and potential risks of the study, as well as details of the insurance covering the patients of the study.
10. Patients receiving treatment with MTX 7.5–25 mg/week for at least 12 weeks, with the last 4 weeks at a stable dose, and willing to remain at this dose for the entire study duration.
11. For WOCBP: negative serum and urine pregnancy test.
12. Ability and willingness to comply with the requirements of the Clinical Study Protocol (CSP).
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1.History of or current inflammatory joint disease other than RA.
2.History of or a current systemic autoimmune disorder with the exception of the secondary Sjögren's syndrome. Patients with a history of or current autoimmune disease confined to a single organ (e.g. thyroiditis or vitiligo) can be considered for enrollment, provided that other eligibility criteria are met.
3.American College for Rheumatology functional Class IV disease
4.History of psychiatric disorder that would interfere with normal participation in this protocol
5.Patient is positive for the current, clinically active or latent infection with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, as determined by the validated serologic, molecular or antigen testing methods and interpreted according to the international diagnostic guidelines
6.History of or current active tuberculosis, with typical symptoms of M. tuberculosis infection confirmed by positive results of TB screening tests or documented diagnosis prior to screening.
7.Latent tuberculosis, as documented in subject's medical records or shown by a positive or indeterminate QuantiFERON test performed at screening, in absence of the typical symptoms of tuberculosis. However, a patient with latent Mycobacterium tuberculosis infection may become eligible for the study, if the following safety criteria are met:
•Patient completed a standard TB prophylaxis prior to the screening and had no active TB or contact with active TB case after completion of the most recent prophylactic regimen. OR
•Patient received at least four weeks of standard TB prophylactic regimen prior to the screening visit and is capable and willing to continue on this regimen while participating in the study
•Patient has no active TB at the time of screening, which must be confirmed through referral to a TB specialist if >1 year has passed since the completion of the last prophylaxis or if the prophylaxis is still being received by the time of screening
•Patient had no positive findings on chest X-ray examination at screening and within three months prior to screening. Patient identified as latently infected with tuberculosis on the screening test may be later re-screened for the study if he/she receives appropriate anti-TB prophylaxis
8.Serious AND/OR uncontrolled coexisting diseases which are recognized as: major contraindications to the administration of rituximab, MTX or any of the pre-medication components OR important risk factors for the development of severe or life-threatening SARS-CoV2 infection OR others, which in the Investigator's opinion, would
preclude patient's participation
9.Treatment with any of the authorized or investigational TNF-a inhibitors at any time before the screening.
10.Recent use of biologic DMARDs or non-biologic DMARDs other than MTX within the washout periods specified in Table 6 2.
11.Prior treatment with a B cell modulating or B cell depleting therapy such as, but not limited to, rituximab or other anti CD20 mAb (ocrelizumab, ofatumumab, obinutuzumab), belimumab, atacicept, tabalumab, epratuzumab and other experimental treatments.
12.Use of systemic glucocorticoids at a dose higher than 10 mg prednisolone daily or equivalent, within 2 weeks prior to Screening OR between Screening and administration of the first IMP dose.
13.Use of intraarticular hyaluronic acid injection within 28 days before the screening OR between Screening and administration of the first IMP dose.
14.Recent vaccin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method