Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 29 November 2021
• Main ID: NCT03830203
• Date of registration: 22/01/2019
• Prospective Registration: No
• Primary sponsor: Bio-Thera Solutions
• Public title: Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
• Scientific title: A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
• Date of first enrolment: December 19, 2018
• Target sample size: 621
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03830203
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Xiaofeng Zeng
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion criteria

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:

1. = 6 out of 68 tender joints (at screening and randomization) AND

2. = 6 out of 66 swollen joints (at screening and randomization) AND

3. Serum C-reactive protein (CRP) > upper limit of normal (ULN) value or erythrocyte
sedimentation rate (ESR) = 28 mm/hour at screening.

3. 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.

4. 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).

5. If female of childbearing potential, subject should have a negative pregnancy test
result at screening and baseline visit.

6. Subjects must be willing to provide written consent and to comply with the
requirements of the study protocol.

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. Subject has received any cell-depleting therapy (eg, rituximab) = 12 months prior to
randomization.

4. Subject has been treated with an investigational drug other than those prohibited or
device = 8 weeks or 5 half-lives of the drug (whichever is longer) prior to
randomization.

5. Subject has undergone joint surgery = 12 weeks prior to randomization (on any joint to
be assessed during the study) or has any surgery planned during the study.

6. 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.

7. 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.

8. 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.

9. Any history of malignancy or lymphoproliferative disease at any time, except curative
treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.

10. Have a transplanted organ/tissue or stem cell transplantation.

11. Subject has an underlying metabolic, hematologic, renal, hepatic, pulmonary,
neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in
the opinion of the investigator places the subject at unacceptable risk.

12. Subject has a history of demyelinating diseases (including myelitis) or neurologic
symptoms suggestive of demyelinating disease.

13. Subject has received any live or attenuated vaccine = 4 weeks prior to randomization
or plans to receive it during the study including the safety follow up period.

14. Subject has a history of clinically significant drug or alcohol abuse in the last 12
months as judged by the investigator.

15. Pregnant or nursing (lactating) women.

16. Subject is considered by the investigator, for any reason, to be an unsuitable
candidate for the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Actemra(EU-licensed)

Drug: BAT1806

Primary Outcome(s)

Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response [Time Frame: 6 months]

Secondary Outcome(s)

Change From Baseline in DAS28 [Time Frame: 1 year]

Secondary ID(s)

BAT-1806-002-CR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors