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Moderate and Severe Rheumatoid ArthritisPhase 2NCT02882087

A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-α Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis

A Phase 2 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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase Ⅱ, placebo-controlled, multicenter, dynamic randomized, double blind study of the efficacy and safety of RC18, a recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein in subjects with inadequate response of TNF-α antagonists due to treat moderate and severe rheumatoid… 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
60 participants
Where
1 siteChina
Study dates
Oct 2015to 25 Feb 2019
Phase
Phase 2
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) 4weeks before randomization .
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  • If the subjects are taking DMARDs (except MTX) at screening, the test was discontinued for at least 4 weeks before randomization.
  • 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

  • -There are serious heart, liver, kidney and other important organs and blood, endocrine system diseases and medical history;
  • Evaluation criteria for severity :
  • liver function ≥2 ULN;
  • Cr >135μmol/L;
  • WBCs<3x 109/L;;
  • hemoglobin<85g/L;
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  • platelet count<80x 109/L.
  • Have a historically active hepatitis or active hepatitis or medical history;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;
  • Immune deficiency, uncontrolled severe infection and patients with active or recurrent peptic ulcer;
  • 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.
  • Receipt of live vaccine within 1 month(excepting for herpes zoster vaccine)
  • 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
  • Infection with herpes zoster or HIV virus at the screening;
  • 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 .
  • 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.
  • Combined with non RA any other systemic inflammatory diseases, including but not limiting to, juvenile chronic arthritis, vertebral arthrosis, limited enteritis (Crohn's disease), ulcerative colitis, psoriatic arthritis, activity of vasculitis or gout. But with secondary drying syndrome of patients need not be excluded.
  • Investigator considers candidates not appropriating for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase II, Placebo-Controlled, Multicenter, Dynamic Randomized, Double Blind Trial of RC18, a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Inadequate Response of TNF-α Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis

This is a phase Ⅱ, placebo-controlled, multicenter, dynamic randomized, double blind study of the efficacy and safety of RC18, a recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein in subjects with inadequate response of TNF-α antagonists due to treat moderate and severe rheumatoid arthritis.

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 MTXDrug

    Also called MTX=Methotrexate

    All patients had a foundation MTX therapy.The researchers evaluated the efficacy of the patient in 12 week.study investigator evaluate the patients of curative effect . The researchers evaluated the efficacy of the patient in 12 week.Evaluation of efficacy in patients if not get the ACR20 response, adjust the treatment plan given the test drug.Test group continue to the test drug,placebo group switch to the test drug.

  • RC18 160 mg plus MTXDrug

    Also called RC18, MTX=Methotrexate

Study groups in NCT02882087
Study groupRoleWhat they receive
Placebo ComparatorExperimentalPlacebo SC plus MTX. Patients received placebo SC weekly administered subcutaneously for 24 times.All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose.The researchers evaluated the efficacy of the patient in 12 week.Evaluation of efficacy in patients if not get the ACR20 response, adjust the treatment plan given the test drug.Test group continue to the test drug,placebo group switch to the test drug.
Receives: Drug: Placebo plus MTX
Experimental: RC18 160 mg plus MTXExperimentalPatients received the test group RC18 160mg weekly administered subcutaneously for 24 times. All patients had a foundation MTX therapy, MTX dose should be stable, not to adjust the dose.
Receives: Drug: 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 24 weeks for visits

    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 (1)

  1. Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28)at week 12 and week 24.

    DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters [mm]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale [VAS]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*square root (√) of TJC + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

    Measured: week 12 and week 24

Timeline

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

  1. First posted29 Aug 2016 (estimated)
  2. Study startOct 2015
  3. Primary completion25 Feb 2019
  4. Study completion25 Feb 2019

Why it stopped: Lack of trial population, unable to recruit subjects

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882087
Sponsor's protocol ID
C004 RACLLI
Status last verified
Apr 2019
First submitted
24 Aug 2016
Last updated
3 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 24 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: stopped early, as of the sponsor's last update on 3 Apr 2019. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Lack of trial population, unable to recruit subjects). Results are not available in the source record.

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 24 weeks for visits (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 NCT02882087.

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 3 Apr 2019.

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Clinical Trial NCT02882087 | AzTrials