A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate; MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-002202-31-BG
• Lead Sponsor: Bio-Thera Solutions, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-30
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 621

Inclusion Criteria

1. Male or female subjects 18 years of age or older who fulfil the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 revised classification criteria for RA diagnosis for at least 6 months before screening, based on the medical history record.
2. Subject presents with active RA, as defined by:
a. 2: 6 out of 68 tender joints (at screening and randomization) AND
b. 2: 6 out of 66 swollen joints (at screening and randomization) AND
c. Serum C-reactive protein (CRP) >upper limit of normal (ULN) value or erythrocyte sedimentation rate (ESR) 2: 28 mm/hour at screening.
3. Subject must be receiving MTX therapy according to the following:
a. MTX treatment by any route of administration for 2: 12 weeks prior to randomization, with at least the last 4 consecutive weeks prior to randomization on a stable dose ranging between 10 to 25 mg/week.
b. Subjects will continue on their stable MTX dose and route of administration throughout the study.
4. If using oral corticosteroids, subject must be on a stable::=:: 10 mg dose ofprednisone/day equivalent for at least 4 consecutive weeks prior to randomization and willing to continue at this level throughout the study.
5. If taking nonsteroidal anti-inflammatory drugs, subject must be on a stable dose for at least 2 consecutive weeks prior to randomization and willing to continue at this level throughout the study.
6. Subjects are eligible if they have received not more than 2 biological agents other than interleukin-6 inhibitors or targeted synthetic DMARDs ( eg, tofacitinib) in total for RA treatment.
7. Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must be willing to take reliable contraceptive precautions throughout the study period and continuing for at least 3 months after the last dose of study drug. Reliable methods of contraception include: intrauterine device, hormonal contraceptives (eg, oral, patch, or injectable), male vasectomy (if vasectomy was medically confirmed), a barrier protection method ( eg, condom or diaphragm) in association with spermicide cream, foam, or gel. Abstinence from heterosexual intercourses is accepted when this is the usual lifestyle of the subject and must be continued for at least 3 months after the last dose of study drug. A female subject is considered not of child-bearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy).
8. If female of childbearing potential, subject should have a negative pregnancy test result at Screening and Baseline visit.
9. Subjects must be willing to provide written consent and to comply with the requirements of the study protocol.

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 553
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

1. Has RA of ACR functional class IV or is wheelchair/bed bound.
2. Known hypersensitivity to tocilizumab or to study treatment excipients.
3. Previous exposure to any authorized or investigational interleukin-6 inhibitor
4. Subject has received any biological agents other than those prohibited or any targeted synthetic DMARDs
5. Subject has received any cell-depleting therapy (eg, rituximab) ::=:: 12 months prior to randomization.
6. Subject has been treated with an investigational drug other than those prohibited or device :S 8 weeks or 5 half-lives of the drug (whichever is longer) prior to randomization.
7. Subject has received any conventional DMARDs other than MTX (eg, hydroxychloroquine, sulfasalazine, iguratimod, etc.)::=:: 4 weeks prior to randomization. For leflunomide, the washout period before randomization must be a minimum of 12 weeks or a minimum of 4 weeks is accepted
after documented completion of standard cholestyramine or activated charcoal washout procedure.
8. Previous exposure to alkylating agents such as cyclophosphamide or chlorambucil.
9. Subject has received IV imrnunoglobulins or plasmapheresis ::=:: 6 months prior to randomization.
10. Subject has been treated with intra-articular or parenteral corticosteroids ::=:: 4 weeks prior to randomization (inhaled corticosteroids for stable medical conditions are allowed).
11. Subject has received any herbal remedies, traditional medicines, or other not approved medications for RA :S 4 weeks prior to randomization.
12. Subject has undergone joint surgery :S 12 weeks prior to randomization (on any joint to be assessed during the study) or has any surgery planned during the study.
13. Evidence of malignancy, lung infection, or abnormalities suggestive of active tuberculosis (TB) on chest radiography performed within 12 weeks prior to the Screening Visit or during the screening period.
14. Subject meets any of the following criteria relative to latent or active TB infection:
a. History of active TB :S 3 years prior to screening. If> 3 years, documentation of completion of adequate therapy must be available.
b. Presence of signs or symptoms suggestive of active TB upon medical history and/or physical examination during screening.
c. Recent close contact with a person with active TB.
d. Positive interferon-gamma release assay (IGRA) result at screening.
15. History of invasive infection (eg, histoplasmosis, coccidioidomycosis, blastomycosis).
16. Presence of active infection at screening, or history of infection requiring intravenous antibiotics and/or hospitalization :S 4 weeks prior to randomization or oral antibiotics :S 2 weeks prior to randomization. Minor fungal infections (eg, minor nail infections) will be allowed.
17. Any recurrent bacterial, fungal, or viral infection that based on the investigator's clinical assessment makes the subject unsuitable for the study, including recurrent/disseminated herpes zoster.
18. Current or history of diverticulitis, complications of diverticulitis, history of diverticulosis requiring antibiotic treatment, current or history of chronic ulcerative lower gastrointestinal tract diseases or any other lower gastrointestinal condition that may predispose to perforation.
19. Any history of malignancy or lymphoproliferative disease at any tin1e, except curative treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.
20. Have a transplanted organ/tissue or stem cell t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified