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Rheumatoid Arthritis (RA)Phase 3NCT02722694

A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Phase 3 study testing Subcutaneous(SC) Abatacept and Methotrexate in people with Rheumatoid Arthritis (RA), run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to demonstrate superior efficacy of abatacept 125mg administrated SC weekly comparing to placebo after 24 weeks treatment in Chinese subjects who have active rheumatoid arthritis, are receiving methotrexate and experiencing an inadequate response to methotrexate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
Subcutaneous(SC) Abatacept and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
1 siteChina
Study dates
Aug 2016to Dec 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects are willing to participate in this study and sign informed consent;
  • Subjects must meet the criteria of the America Rheumatism Association (1987) for the diagnosis of rheumatoid arthritis and ACR (1991) functional classes I, II or III;
  • Subjects must have had Rheumatoid Arthritis for at least 6 months;
  • Subjects who have inadequately response to MTX, must have been taking methotrexate for at least 3 months with minimal dose of 10 mg weekly, and at a stable dose for at least 28 days prior to randomization (Day 1). Methotrexate weekly dose as low as 7.5 mg is permitted for subjects who cannot tolerate higher dose, and the intolerance of higher dose than 7.5mg weekly should be well documented;
  • Subjects must have the following disease activity at randomization:
  • 6 or more swollen joints(66 joint count);
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  • 8 or more tender joints(68 joint count); and
  • C reactive protein (hsCRP) > 3 mg/L (based on the result of screening visit) or ESR ≥ 28mm/hr;
  • All DMARDs (except methotrexate) should be discontinued for at least 28 days prior to study randomization (Day 1), Leflunomide must have been discontinued ≥8 weeks (the subject can be washed-out with cholestyramine according to label recommendations);
  • Oral corticosteroid treatment must have been reduced to the prednisone ≤ 10 mg daily or equivalent for 28 days，and stabilized for at least 25 out of 28 days prior to randomization (Day 1). Corticosteroid administered by intra-articular (IA) or intramuscular (IM) will not be allowed 28 days prior to randomization (Day 1);
  • Stable NSAIDs are permitted;
  • Male and female subject ≥18 years old;
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study medication;

Who cannot join

  • WOCBP and male patients of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study medication;
  • Women who are pregnant or breast-feeding;
  • Women with a positive pregnancy test on enrollment or prior to study drug administration;
  • Subjects meet diagnosis criteria of other rheumatoid disease (e.g., systemic lupus erythematosus);
  • Subjects with active vasculitis of the major organ systems (except for subcutaneous rheumatoid nodules);
  • Current symptoms of severe, progressive or uncontrolled diseases of renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study;
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  • Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Subjects with carcinoma in situ, treated with definitive surgical intervention, are allowed;
  • Subjects who have a history of drug or alcohol abuse;
  • Subjects with any serious bacterial infection within the last 3 months (such as pneumonia or pyelonephritis, unless treated and resolved with antibiotics);
  • Subjects with serious, chronic or recurrent bacterial infection (such as recurrent pneumonia and chronic bronchiectasis);
  • Subjects at risk for tuberculosis (TB), Specially, :
  • Having evidences of clinical, imaging or lab test of current active or latent pulmonary tuberculosis;
  • Having active pulmonary tuberculosis during the past 3 years, even if had treated;
  • Having history of active pulmonary tuberculosis more than 3 years ago, unless the appropriate duration and types of anti-tuberculosis drug is well documented;
  • Subjects with herpes zoster that resolved less than 2 months before enrollment;
  • Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection;
  • Subjects are impaired, incapacitated, or incapable of completing study related assessment;
  • Hepatitis-B surface antigen-positive subjects.
  • Hepatitis C antibody-positive subjects
  • HIV antibody-positive subjects
  • Subjects with any of the following laboratory values:
  • Hgb < 85 g/L
  • white blood cell count < 3,000/mm3(3×10^9/L)
  • Platelets < 100,000/mm3(100×10^9/L);
  • Creatinine clearance < 40 mL/min;
  • Serum glutamic pyruvic transaminase (GPT or ALT) or glutamic oxaloacetic transaminase (GOT or AST)>2 times upper limit of normal;
  • Any other laboratory test results that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study;
  • Subjects who have received treatment with rituximab at any time;
  • Subjects who had prior exposure to abatacept or CTLA4-Ig;
  • Subjects who have received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) (whichever is longer);
  • Subjects currently (when signing informed consent) treated with an anti-tumor necrosis factor (TNF) therapy, such as adalimumab and infliximab (within 8 weeks of the last dose), or etanercept (within 4 weeks of the last dose);
  • Subjects who discontinued an approved biologic RA therapy due to lack of efficacy in the past;
  • Subjects exposed to multiple (>3) approved biologic RA therapies in the past;
  • Subjects currently treated with anakinra unless a minimum 4-week wash-out period has been completed before Day 1;
  • Subjects who received prior treatment with any investigational biologic not currently approved;
  • Subjects who had been exposed to any approved biologic within 4 weeks or 5 half-lives, whichever was longer;
  • Subjects are (when signing informed consent)receiving an investigational biologic RA therapy or an approved biologic RA therapy;
  • Subjects who have received any active vaccine within 3 months of the first dose of the study medication or plan to receive active vaccine during the study;
  • Prisoners or subjects who are involuntarily incarcerated;
  • Subjects who are compulsorily detained for treatment either a psychiatric or physical (e.g., infectious disease) illness;
  • Subjects who are illiterate.

Trial locations and contacts

1 site in 1 country.

Xiaofeng Zeng contact

86-10-69158793

xiaofeng.zeng@cstar.org.cn

China1 site, 1 recruiting

  • Peking union medical college hospital

    Beijing, Beijing Municipality

    Xiaofeng Zeng, 86-10-69158793, xiaofeng.zeng@cstar.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept 125mg Administered Subcutaneously in Chinese Subjects With Active Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

The primary objective of this study is to demonstrate superior efficacy of abatacept 125mg administrated SC weekly comparing to placebo after 24 weeks treatment in Chinese subjects who have active rheumatoid arthritis, are receiving methotrexate and experiencing an inadequate response to methotrexate. This will be estimated by the proportion of subjects meeting the American College of Rheumatology (ACR) criteria for 20% improvement (ACR20).

Being tested
Subcutaneous(SC) Abatacept, Placebo, Methotrexate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Subcutaneous(SC) AbataceptDrug

    Also called Orencia

    Subjects received 125mg weekly SC abatacept injections for 24 weeks. All subjects who complete 24 weeks double-blind treatment are eligible to enter open label period. During this period, subjects in placebo group will be switched to receive abatacept 125mg administered SC weekly till week 52. Subjects in abatacept group will continue to receive abatacept 125mg weekly.

  • PlaceboOther

    Subjects received weekly SC placebo injections for 24 weeks

  • MethotrexateDrug

    All Subjects received backup Methotrexate treatment.

Study groups in NCT02722694
Study groupRoleWhat they receive
Subcutaneous(SC) AbataceptExperimentalNot described
Receives: Drug: Subcutaneous(SC) Abatacept; Drug: Methotrexate
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo; Drug: Methotrexate

What is being measured

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

  1. The proportion of subjects meeting ACR 20 at 24 weeks (Day 169)

    The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).

    Measured: Day 169

Secondary outcomes (3)

  1. The proportion of subject meeting Health Assessment Questionnaire Disability Index (HAQ-DI) improvement at 24 weeks (Day 169)

    The HAQ questionnaire includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.

    Measured: Day 169

  2. The proportion of subjects meeting ACR 50 at 24 weeks (Day 169)

    The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).

    Measured: Day 169

  3. The proportion of subjects meeting ACR 70 at 24 weeks (Day 169)

    The ACR 70 definition of improvement is a 70% improvement from baseline in the number of tender and swollen joint counts, and a 70% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).

    Measured: Day 169

Timeline

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

  1. First posted30 Mar 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02722694
Sponsor's protocol ID
SIM-126-III
Status last verified
Aug 2016
First submitted
10 Mar 2016
Last updated
13 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Subcutaneous(SC) Abatacept and Methotrexate in people with Rheumatoid Arthritis (RA), run by Jiangsu Simcere Pharmaceutical 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 13 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. 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?

Results are not available in the source record.

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

Contact Xiaofeng Zeng (86-10-69158793, xiaofeng.zeng@cstar.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects meeting ACR 20 at 24 weeks (Day 169) (time frame: Day 169). 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 NCT02722694.

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 13 Sep 2016.

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