AzTrials
AzTrials

Moderate and Severe RheumatoId ArthritisPhase 3NCT03016013

A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

A Phase 3 study testing RC18 160 mg plus MTX in people with Moderate and Severe RheumatoId Arthritis, run by RemeGen Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to initially access the safety and effectivity of RC18 combined with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Moderate and Severe RheumatoId Arthritis
What is being tested?
RC18 160 mg plus MTX
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
479 participants
Where
1 siteChina
Study dates
29 Mar 2017to 29 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of adult onset RA by a physician as defined by the 1987 and/or 2010 ACR criteria and ESR or C - reaction protein ( CRP ) is greater than the normal range;
  • Aged 18-65 years old;
  • Consent to use effective contraception during the study period (women of childbearing age);
  • Patients with an inadequate response to existing therapies at least one anti-TNFs Infliximab (Remicade ) at least three times, adalimumab (Humira), at least four times, etanercept ( Enbrel) use at least 8 weeks, etanercept use at least 8 weeks.And Last medication time to randomization more than 12 weeks;
  • Voluntarily signed informed consent;
  • Patients have been taking MTX for at least 12 weeks at the screening and maintaining dose stability ≥7.5mg/ weeks (or equivalent dose) 4 weeks before randomization;
Show all 10Show fewer
  • Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD) /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD;
  • If subjects are receiving treatment of corticosteroid, must stabilize dose (dose of prednisone) at least equal to or less than 10mg/day for 4 weeks (before randomization);
  • If subjects are receiving treatment of NSAIDs,must stabilize dose (dose of prednisone) at least 4 weeks (before randomization);
  • When the patient's condition to achieve moderate to severe active RA at the screening, defined as at least 6/68 tenderness joints and at least 6/66 swollen joints.

Who cannot join

  • The subjects with any other inflammatory arthritis (such as juvenile chronic arthritis, regional enteritis (Krohn S disease), ulcerative colitis, gout, active vasculitis, psoriatic arthritis or ankylosing spondylitis);
  • The subjects with secondary, non inflammatory arthritis (such as osteoarthritis or fibromyalgia), and researchers think the symptoms of arthritis can interfere with judgment and evaluation study on therapeutic effects of drugs.But secondary Sjogren syndrome (SjÖgren), thyroiditis without exclusion;
  • The subjects had a history of prosthetic joint infection, whenever the infection occurred, and the artificial joint is still in the body;
  • The subjects due to RA and/or shoulder hand syndrome IV grade received more than 3 times the arthroplasty;
  • The subjects' Types of X-ray phases reach IV phase.
  • The subjects can not accept the prohibited drugs listed in the following table:
Show all 44Show fewer
  • Use of analgesics (acetaminophen / paracetamol) within 24 hours before baseline assessment;
  • dosage regimen of nonsteroidal anti-inflammatory analgesic NSAIDs/COX-2 inhibitors (except acetaminophen) have occurred any change within 14 days before baseline assessment;
  • The dosage of oral glucocorticoids have occurred any change within 28 days before baseline assessment;
  • Intramuscular injection/intravenous injection/intra-articular injection of glucocorticoid has used within 28 days before baseline assessment;
  • Intra-articular injection of hyaluronic acid has used within 28 days before baseline assessment;
  • Tripterygium wilfordii or other traditional Chinese medicine for treating RA has used within 28 days before baseline assessment.
  • The researchers confirmed that the subjects had current or recent severe, progressive and or not controlled heart, lung, liver, kidney and other important organs and blood, endocrine system lesions and history; Abnormal laboratory parameters need to be excluded, including but not limited to:
  • Cr >135μmol/L or 5 times the upper limit of laboratory reference value;
  • WBCs<3x 109/L;
  • neutrophile granulocyte <1.5×109/L;
  • hemoglobin<85g/L;
  • platelet count<80x 109/L;
  • total bilirubin > 1.5 times the upper limit of laboratory reference value;
  • AST > 2 times the upper limit of laboratory reference value;
  • ALT > 2 times the upper limit of laboratory reference value;
  • alkaline phosphatase > 2 times the upper limit of laboratory reference value.
  • HBsAg-surface antigen positive patients are not allowed to be selected, but only anti HBC single positive is added to do HBV-DNA quantitative detection, if the HBV-DNA quantity is negative can not be regarded as the exclusion.
  • The anti-HCV of patients show positive.
  • Infection with herpes zoster or HIV virus at the screening.
  • The subjects at high risk of infection ;such as leg ulcers, indwelling catheter, persistent or recurrent chest infection, completely bedridden or sedentary wheelchair subjects.
  • There is a history of chronic infection, severe or life-threatening infections (including shingles) within the last 6 months, or any signs or symptoms during the screening period that may indicate an infection (e.g. fever, cough).
  • the subjects currently or recently (30 days before screening) suffers from severe viral, bacterial, fungal, or parasitic infections.
  • pregnant, lactating women and men or women who have birth plans in the past 6 months.
  • Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines.
  • The subjects receive live vaccine/attenuated vaccine within the first 8 weeks before screening or those who are known to receive live vaccine/attenuated vaccine during the trial.
  • Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the elderly).
  • Patients with using of biological agents for the treatment of DMARDs within three months.
  • Active TB at screening.Exception for patients with PPD≥15mm.But Patients with anti tuberculosis treatment for 3 years without relapse are allowed to participate in the trial.
  • Malignant tumor patients :the patients who suffering from malignant tumor has been removed and no recurrence or who with cervical carcinoma in situ have evidence of metastatic disease and with basal cell or squamous cell carcinoma had been completely removed and at least 3 years without recurrence can participate in.
  • The patients with a history of lymphoproliferative disease (including lymphoma or signs and symptoms of lymphoproliferative disease at any time).
  • the patients have no effective in using of tumor necrosis factor inhibitors;
  • there was a history of long-term alcohol abuse, intravenous drug abuse or other illicit drug abuse within 6 months.
  • Planning to have surgery for RA or other significant surgery during the period of the study.
  • patients experienced any of the following events within 12 weeks before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association class IV heart failure.
  • Patients received interferon treatment (such as interferon alpha, intron alpha, peg-intron, double talon, intergen, Pegasys etc.) within 4 weeks before screening,or are expected to test period will need to accept interferon therapy.
  • The combined use of immunosuppressive agents associated with organ. transplantation is not allowed during the study period.
  • Immunosuppressive agents associated with organ transplantation should not be allowed during the study period.
  • Investigator considers candidates not appropriating for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Phase III Study of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects with Poor Efficacy of MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

The purpose of this study is to initially access the safety and effectivity of RC18 combined with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.

Being tested
Placebo plus MTX, RC18 160 mg plus MTX
Medical subject headings
Lymphoma, Follicular, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo plus MTXBiological

    Also called MTX=Methotrexate

    The trial was divided into two groups: (1) placebo + MTX; (2) telitacicept 160 mg + MTX. MTX was used as the basic treatment, the dose of MTX was stable during the trial, and could not be adjusted. Telitacicept or placebo was administered once a week for the first 24 weeks. Beginning at week 24, subjects in the placebo group will enter the RC-18 treatment group. All subjects received RC-18 treatment once a week from week 24 to week 48.

  • RC18 160 mg plus MTXBiological

    Also called RC18, MTX=Methotrexate

    The trial was divided into two groups: (1) placebo + MTX; (2) telitacicept 160 mg + MTX. MTX was used as the basic treatment, the dose of MTX was stable during the trial, and could not be adjusted. Telitacicept or placebo was administered once a week for the first 24 weeks. Beginning at week 24, subjects in the placebo group will enter the RC-18 treatment group. All subjects received RC-18 treatment once a week from week 24 to week 48.

Study groups in NCT03016013
Study groupRoleWhat they receive
Placebo plus MTXPlacebo comparatorPatients received placebo SC plus MTX weekly administered subcutaneously for 24 times.All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose. All subjects received RC-18 treatment once a week from week 24 to week 48.
Receives: Biological: Placebo plus MTX
Experimental: RC18 160 mg+MTXExperimentalPatients received the test group RC18 160mg plus MTX weekly administered subcutaneously for 24 times. All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose.
Receives: Biological: RC18 160 mg plus MTX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients in each group reached ACR20 at week 24

    ACR20 response: Patients with tenderness and swollen joint counts and 20% improvement,At least 3 20% improvement in the following 5:a.Health Assessment Questionnaire;b.Subjects assessed pain VAS score;c.Assess the overall situation of the disease subject VAS score;d.Researchers assessed the overall situation of the disease in the VAS score;e.Acute phase reactants(ESR or CRP).

    Measured: Week 24（Visit 9）

Secondary outcomes (6)

  1. Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 24.

    Measured: Week 24

  2. Percentage of Participants Achieving Low Disease Activity and clinical remission. (DAS28 ≤3.20 and DAS28 < 2.6).

    Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.

    Measured: Week 24

  3. Percentage of Participants Achieving American College of Rheumatology ACR50 and ACR70 Responses at week 12 or week 24.

    Measured: Week 12 and Week 24

  4. Sharp Score Relative Change from Baseline at Week 24

    Measured: Week 24

  5. Percentage of Participants With American College of Rheumatology 20% ,50% and 70% (ACR20, ACR50 and ACR70) Response

    Measured: Week 4, Week 8, Week 12, Week 28, Week 32, Week 40, Week48

  6. Change From Baseline in Joint Space Narrowing and Erosions at week 24 and week 48.

    Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion).And Joint space narrowing score (a component of the modified TSS) also is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing).

    Measured: Week 24,Week48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2017 (estimated)
  2. Study start29 Mar 2017
  3. Primary completion19 Nov 2022
  4. Study completion29 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
479 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016013
Sponsor's protocol ID
C008 RACLLI
Status last verified
Sep 2023
First submitted
8 Jan 2017
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RC18 160 mg plus MTX in people with Moderate and Severe RheumatoId Arthritis, run by RemeGen Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients in each group reached ACR20 at week 24 (time frame: Week 24（Visit 9）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03016013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in