A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 282

Inclusion Criteria

Parts A and B:
1. Male or female outpatient, between 18 and 80 years of age at Screening
2. Severe RA defined as:
- Diagnosis of RA according to the revised (1987) ACR criteria for the classification of RA for at least 3 months prior to screening visit.
- And =6 swollen joints and =6 tender/painful joints (from the 66/68 joint count system)
- And C-reactive protein (CRP) =1.0 mg/dL or an ESR =28 mm/hour at Screening
- And positive RF (=20 units/mL) or anti-CCP antibodies (=10 units/mL) at Screening
3. Patients with severe RA who have had an inadequate response to at least 3 months’ treatment (according to the approved treatment and dosage) or intolerance (at Investigator's discretion and/or experience of intolerable AE or toxicity such as infusion related reaction, hypersensitivity, anaphylaxis or severe toxicity) to anti-TNF therapy (experience of severe AE or toxicity).
4. Current treatment for RA on an outpatient basis:
- Receiving MTX 7.5 - 25mg/week (oral or parenteral) for at least 12 weeks, including the last 4 weeks prior to Day 1 at a stable dose, via the same route of administration, dose, and formulation. Patients receiving a lower dose of MTX (<10 mg/week), stable for 4 weeks prior to Day 1, should be doing so as a result of a documented evidence of intolerance to higher doses of MTX.
- Leflunomide must be withdrawn at least 12 weeks prior to Day 1 or a minimum of 4 weeks prior to Day 1 if after 11 days of standard cholestyramine washout.
- All DMARDs different from MTX and leflunomide must be withdrawn at least 4 ~ 8 weeks prior to Day 1.
- If receiving current treatment with oral corticosteroids, the dose must not exceed 10 mg/day prednisone or equivalent. During the 4 weeks prior to Day 1 the dose must be stable.
- The most recent IM/intra-articular steroid injection should be ?6 weeks prior to Day 1.
- If receiving current treatment with NSAIDs at the time of Screening, the patient must remain on a stable dose for at least 3 weeks prior to Day 1.
- Patients are willing to receive oral folic or folinic acid or equivalent during the entire study (mandatory co-medication for MTX treatment), according to local standards and availability.
5. Men and women of childbearing potential must use highly effective methods of contraception during the course of the treatment period and for at least 12 months after the last infusion of study drug. A man or women is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active. Examples of highly effective contraception include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:
* oral
* intravaginal
* transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation 1:
* oral
* injectable
* implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
6. Female patients of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at each applicable visit thereafter. Females will be considered to be of no

Exclusion Criteria

Parts A and B:
1 Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
2 Class IV as per the Classification of Global Functional Status in Rheumatoid Arthritis (as per ACR 1991 Revised Criteria) or wheelchair/bed-bound.
3 History of or current inflammatory joint disease other than RA
4 History of or current systemic autoimmune disorder with the exception of the secondary Sjögren's syndrome.
5 Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection or positive test at screening.
Part C only:
1. Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
2. Patients with IgG levels at Week 36 <300 mg/dL. IgG may be
repeated one time to establish eligibility upto 4 weeks prior to the 1st infusion of the 3rd course.
3. Patients with ANC at Week 36 <1,500 cells/µL. ANC may be repeated one time to establish eligibility upto 4 weeks prior to the 1st infusion of the 3rd course.
4. Any significant cardiac disease.
5. Patients who, based on the Investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may also include cardiovascular, vascular, pulmonary, hepatic, renal, endocrine or neurological conditions as determined by medical history, physical examination, or laboratory tests or electrocardiogram (ECG).
6. Patients who, in the judgment of the Investigator, are likely to be non-compliant or uncooperative during the study.

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

Updated 1/24/2022

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

Updated 3/10/2014