A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2019-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the efficacy and safety of rituximab compared with placebo in SSc patients. This study consists of a 24-week, double-blind, placebo-controlled period followed by a 24-week active drug treatment period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

NCT06297096

Systemic Sclerosis Interstitial Lung Disease

NOT_YET_RECRUITING PHASE3

A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

NCT03957681

Moderate to Severe Systemic Sclerosis

COMPLETED PHASE3

Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis

NCT02465437

Diffuse Cutaneous Systemic Sclerosis

TERMINATED PHASE2

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

NCT05878717

Systemic Sclerosis Associated Interstitial Lung Disease Scleroderma, Systemic

RECRUITING PHASE2/PHASE3

A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients

NCT04837131

Systemic Sclerosis Scleroderma Diffuse Systemic Sclerosis +16 more

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scleroderma, Systemic Skin Sclerosis Lung Fibrosis Autoimmune Diseases Collagen Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Double-Blind Placebo

Participants will receive double-blind matching placebo from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48.

Group Type PLACEBO_COMPARATOR

Double-Blind Placebo

Intervention Type DRUG

The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.

In the double-blind period, one cycle of placebo will be administered. In the active drug period, one additional cycle (rituximab) will be administered.

Double-Blind Rituximab

Participants will receive double-blind rituximab from baseline until week 24. Participants may then receive open-label rituximab from weeks 24 to 48.

Group Type EXPERIMENTAL

Double-Blind Rituximab

Intervention Type DRUG

The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.

In the double-blind period, one cycle of rituximab will be administered. In the active drug period, one additional cycle (rituximab) will be administered.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Double-Blind Placebo

The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.

In the double-blind period, one cycle of placebo will be administered. In the active drug period, one additional cycle (rituximab) will be administered.

Intervention Type DRUG

Double-Blind Rituximab

The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.

In the double-blind period, one cycle of rituximab will be administered. In the active drug period, one additional cycle (rituximab) will be administered.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Fulfill the diagnostic criteria for systemic sclerosis defined in the 2016 edition of the Clinical Practice Guidelines for Systemic Sclerosis and have an mRTSS of 2 (moderate) or higher for skin sclerosis
2. Aged 20 or older and younger than 80 at the time of consent
3. Have an expected survival of at least 6 months (and expected to allow 6 months of observation)
4. Fulfill the following criteria related to concomitant medications/therapies:

* Not received corticosteroids equivalent to more than 10 mg/day of prednisolone within 2 weeks before the start of study treatment; and
* Not received antifibrotic agents (like nintedanib, pirfenidone, tocilizumab), other investigational products, immunosuppressants (cyclophosphamide, mycophenolate mofetil, ciclosporin, tacrolimus, azathioprine, and mizoribine), high-dose intravenous immunoglobulin, or imatinib 4 weeks prior to the start of study treatment.
5. Provided written consent to participate in the study

Exclusion Criteria

1. Present with pulmonary hypertension\* associated with systemic sclerosis

\*: The patient will undergo echocardiography during the pre-treatment observation period to exclude pulmonary hypertension. The patient will be required to undergo examination by an expert (eg, at the Department of Cardiovascular Medicine) if systolic pulmonary artery pressure exceeds 35 mmHg.
2. Have serious complications (eg, renal crisis) associated with systemic sclerosis (excluding interstitial pneumonia\*\*)

\*\*: Patients with interstitial pneumonia will be excluded if the criterion 3) below is met.
3. Have only poor respiratory reserve (%VC or %DLco, both calculated using the "estimation equation more suitable for Japanese," is less than 60% or 40%, respectively)
4. Known to have HIV antibodies
5. Have a positive result for any of the following: HBs antigen, HBs antibody, HBc antibody, and HCV antibody (this criterion does not apply to a positive test for hepatitis B clearly attributable to hepatitis vaccination)
6. Have serious bacterial/fungal infections
7. Have a serious liver disease (AST \[GOT\] or ALT\[GPT\] of ≥ 300 IU)
8. Have a serious renal disease (serum creatinine ≥ 2.0 mg/dL)
9. Have severe heart disease
10. Have active tuberculosis
11. Have any known malignancy or a history of malignancy within the past 5 years
12. Have a history of serious infections
13. Have a history of serious hypersensitivity or anaphylactic reactions to any component of rituximab or to mouse proteins
14. Pregnant, postpartum, and lactating women
15. Refuse to practice contraception from the time of consent to at least 12 months after study completion
16. Have any disease or physical/psychiatric conditions that make study participation difficult/inappropriate
17. Received other investigational products within 12 weeks prior to the study treatment or are participating in other clinical research/studies
18. Smoked within 12 weeks prior to the date of consent
19. Is determined by the investigator (or sub-investigator) to be ineligible for the study for any other reason

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No