A phase III clinical study in patients with active rheumatoid arthritis who show an inadequate response or intolerance to previous or current treatment

JRCT ID: jRCT2011220026

Registered date:28/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 01/12/2022
• Target sample size: 113
• Study type: Interventional

Intervention(s)

Intravenous administration of IDEC-C2B8 or placebo
1. Blinded phase: 1,000 mg per body per dose of IDEC-C2B8 or placebo is administered every two weeks for two doses in total.
2. Rescue therapy period: IDEC-C2B8 1,000 mg per body per dose will be administered every two weeks for two doses in total if a new therapeutic intervention is considered necessary from Week 16 to 23 after the day of administration of the first dose of IDEC-C2B8 or placebo in the blinded period.
3. Readministration: IDEC-C2B8 1,000 mg per body per dose will be administered every two weeks for two doses in total if the study is continued up to Week 24 after the day of administration of the first dose of IDEC-C2B8 or placebo in the blinded period but new therapeutic intervention is deemed necessary.

Outcome(s)

• Primary Outcome: The proportion of patients with ACR20 response at Week 24 after the day of administration of the first dose of IDEC-C2B8 or placebo in the blinded period

Secondary Outcome

1. The proportion of patients with ACR20, ACR50 and ACR70 responses
2. The proportion of patients with low disease activity and remission observed in DAS28-ESR, DAS28-CRP, CDAI and SDAI, and the change from screening
3. The proportion of patients who met the EULAR improvement criteria (Good Response and Moderate Response)
4. Changes in each item in the ACR core set
5. Changes in SF-36 (PCS, MCS) and FACIT-F from screening
6. Changes in total Sharp/van der Heijde score, Joint Space Narrowing score, and Erosion Score from screening

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Japanese patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR Classification Criteria for Rheumatoid Arthritis.
2. Patients to whom either (1) or (2) below applies:
(1) Have active disease and history of treatment with at least one approved bDMARD or JAK inhibitor but who have had difficulty continuing treatment due to lack of response or to drug intolerance.
(2) Have history or comorbidity (including suspected) of malignant lymphoma, lymphoproliferative disease, malignancy, or demyelinating diseases.
3. Patients who have been diagnosed with rheumatoid arthritis for six months or longer.
4. Patients who are at 18 years of age or older at the time of consent to participate in this study.
5. Patients who have sufficiently understood the objectives, details, and risks of the study and have themselves provided written consent to participate in the study of their own free will.

Exclude criteria

1. Patients who received or are scheduled to receive disease-modifying antirheumatic drugs within 4 weeks or infliximab within 6 weeks prior to the first administration of IDEC-C2B8 or placebo in the blinded period.
2. Patients who have newly started treatment with methotrexate, changed the dosage form of methotrexate, or changed or discontinued their weekly methotrexate dose within 4 weeks before enrollment.
3. Patients who have newly started treatment with csDMARDs (excluding csDMARDs continued from 4 weeks or more before enrollment), changed the type and the dosage form of csDMARDs, or changed or discontinued the dose (csDMARDs consist of sodium aurothiomalate, bucillamine, salazosulfapyridine, leflunomide, tacrolimus hydrate, and iguratimod) within four weeks before enrollment.
4. Patients who have newly started treatment with glucocorticosteroids, changed the type of glucocorticosteroids, or changed glucocorticosteroid dose (including discontinuation of treatment with glucocorticosteroids), within 4 weeks before enrollment.
5. Patients with a history of treatment with anti-CD20 monoclonal antibody including rituximab (genetic recombination), within 1 year before enrollment.
6. Pregnant women, women testing positive on pregnancy test, women giving birth, or breastfeeding women.
7. Patients who have previously undergone surgical treatment on more than three joints for rheumatoid arthritis, including synovectomy, arthroplasty, joint replacement surgery, and joint fusion surgery.
8. Patients who have tuberculosis or a history of active tuberculosis within 3 years before enrollment.
9. Patients to whom either of (1) or (2) below applies:
(1) Confirmed positive test for HIV antibody
(2) Positive test for at least one of the following: HBs antigen, HBs antibody, HBc antibody, or HCV antibody
10. Patients with severe psychiatric disorders.

Related Information

• Primary Sponsor: Okugaito Izumi