Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients
NCT ID: NCT01915537
Last Updated: 2013-08-05
Study Results
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.
UNKNOWN
NA
170 participants
INTERVENTIONAL
2013-08-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary objectives are compare the differences of laboratory measurements, clinical remission rate, function score and imageological evaluation between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 14, 30, 54 and 102.
Infliximab arm：Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then once every 8 weeks, MTX\>7.5mg per week. To observe the results at week 14, 30, 54 and 102 after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after remission for a period of time in good economic condition patients while receiving MTX with hydroxychloroquine(HCQ) or leflunomide(LEF) in poor economic condition patients.
Classic DMARDs treatment arm： Classic DMARDs treatment combination of 2 or 3 drugs, 2-drugs combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF or Thunder God Vine for total 30 weeks.
Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF after remission for a period of time.
Study is divided into three stages First stage: day -7 to 0
1. Sign informed consent;
2. Examine and verify the inclusion and exclusion criteria;
3. Collect the data of demographic characteristics, history of present illness, signs and symptoms, history of previous illness and concomitant medicine, personal history, allergic history, injury and surgery history;
4. Data of laboratory examinations: Rheumatoid Factor(RF),anti citrullinated protein antibodies(ACPA) ;
5. Safety data: vital signs, blood routine examination, biochemical test;
6. Efficacy data: Erythrocyte Sedimentation Rate(ESR), C Reactive Protein(CRP), 28 joints disease activity score(DAS28 score), Simplified disease activity index(SDAI) score, American College Of Rheumatology(ACR)/European League Against Rheumatism(EULAR) remission ,Sharp van der Heijde scoring(SHARP) score, Magnetic Resonance Imaging(MRI) score, Health Assessment Questionnaire(HAQ) score;
Second stage: week 0 to week 30, follow-up duration I The subjects are randomized assigned to achieve experimental or control treatment for 30 weeks and follow up at week 2, 6, 14, 22 and 30.
1. The follow up items are same at week 2 and week 22: signs and symptoms, ESR, CRP;
2. The follow up items at week 6: signs and symptoms, blood routine examinations, biochemical test, ESR, CRP;
3. The follow up items at week 14: signs and symptoms, ESR, CRP, DAS28 score, SDAI score, ACR/EULAR remission, SHARP score, MRI score, HAQ score;
4. The follow up items at week 30: signs and symptoms, RF, ACPA, blood routine examinations, biochemical test, ESR, CRP, DAS28 score, SDAI score, ACR/EULAR remission, SHARP score, MRI score, HAQ score.
Third stage: Week 30 to 102, follow-up duration II After 30 weeks treatment the subjects are into 72 weeks follow-up duration, the follow up will be conducted at week 38, 46, 54 and 102.
1. The follow up items are same at week 38 and 46: signs and symptoms, ESR, CRP;
2. The follow up items: signs and symptoms, blood routine examinations, biochemical test, ESR, CRP, DAS28 score, ACR/EULAR remission, SHARP score, MRI score, HAQ score;
3. The follow up items at week 102: signs and symptoms, RF, ACPA, blood routine examinations, biochemical test, ESR, CRP, DAS28 score, SDAI score, ACR/EULAR remission, SHARP score, MRI score, HAQ score.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infliximab group
Infliximab with MTX treatment
Infliximab group
Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then once every 8 weeks, MTX\>7.5mg per week. To observe the results at week 14, 30, 54 and 102 after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after remission for a period of time in good economic condition patients while receiving MTX with HCQ or LEF in poor economic condition patients.
Classic DMARDs treatment group
Classic DMARDs treatment（MTX 、LEF 、HCQ 、 LEF ）
Classic DMARDs treatment group
Classic DMARDs treatment: combination of 2 or 3 drugs, 2-drugs combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF or Thunder God Vine for total 30 weeks.
Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF after remission for a period of time.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infliximab group
Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then once every 8 weeks, MTX\>7.5mg per week. To observe the results at week 14, 30, 54 and 102 after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after remission for a period of time in good economic condition patients while receiving MTX with HCQ or LEF in poor economic condition patients.
Classic DMARDs treatment group
Classic DMARDs treatment: combination of 2 or 3 drugs, 2-drugs combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF or Thunder God Vine for total 30 weeks.
Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF after remission for a period of time.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age is from 18 to 70 years old
3. To accord with the diagnostic criteria of ACR/EULAR 2010 and the course of disease is less than 2 years;
4. Active RA, DAS28 score is above 5.1
5. At least has one poor prognostic factor including:(1)functional limitations,(2)extra-articular manifestation,(3)positive RF or Anti-Cyclic Citrullinated Peptide(CCP) antibody ,(4)X- ray confirmed bone erosion.
Exclusion Criteria
2. Abnormal liver function, the level of alanine aminotransferase(ALT) and aspartate amino transferase(AST) is higher than 3 times of upper limit of normal (ULN);
3. Renal dysfunction, the level of serum creatinine is higher than 1.5 times of ULN;
4. Receive live virus or bacterial vaccination currently or 4 weeks before recruitment into the study;
5. Previously affected by tuberculosis or with positive tuberculin test result;
6. Has history of lymphoproliferative disease such as lymphoma or suspected lymphoproliferative disease through signs and symptoms such as lymphadenectasis in posterior cervical triangle, interclavicular or supratrochlear, or splenomegaly (more than 2 cm below the ribs);
7. History of multiple sclerosis or other demyelinating diseases of central nervous system;
8. Be allergic to experimental drug or with serious allergic constitution;
9. Malignancies excluding cured skin basal cell carcinoma or carcinoma in situ of cervix;
10. Systemic active infection, HIV infection or active Hepatitis B or Hepatitis B virus carriers;
11. With serious medical diseases such as cardiac insufficiency (), myocardial ischemia, serious arrhythmia, renal insufficiency, serious liver dysfunction, significant hematological system diseases, hypercortisolism, uncontrollable hypertension and diabetes mellitus;
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Central South University
OTHER
Tianjin Medical University General Hospital
OTHER
Xijing Hospital
OTHER
Zhang, Xiao, M.D.
INDIV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhang, Xiao, M.D.
Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiao Zhang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
XIJING Hospital
Xi’an, Shanxi, China
Tianjin medical university general hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jinwei Chen, Bachelor
Role: primary
Zhenbiao Wu, Ph.D
Role: primary
Wei Wei, Master
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INNOVATION
Identifier Type: -
Identifier Source: org_study_id