Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients

NCT01915537 | Unknown DMC

• 1 other identifier: INNOVATION
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, multi-centric, cohort study to observe the efficacy difference between intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever rheumatoid arthritis(RA) 28 joints disease activity score\>5.1(DAS28\>5.1) patients with poor prognostic factors.Primary objective is compare the difference of clinical remission rate between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 30.

Conditions

Rheumatoid Arthritis（RA）

Keywords

poor prognosis; severe RA; infliximab

Outcome Measures

Primary Outcomes (1)

• The rate of subjects achieving DAS<2.6

  The rate of subjects achieving DAS\<2.6 at week 30

  at week 30

Secondary Outcomes (8)

• The rate of subjects achieving DAS<2.6

  at week 14, 54 and 102

• The rate of subjects achieving SDAI<3.3

  at week 14, 30, 54 and 102

• The rate of subjects achieving ACR/EULAR remission

  at week 14, 30, 54 and 102

• MRI score

  at week 14, 30, 54 and 102

• The HAQ score

  at week 14, 30, 54 and 102

Study Arms (2)

Infliximab group

EXPERIMENTAL

Infliximab with MTX treatment

Drug: Infliximab group

Classic DMARDs treatment group

ACTIVE COMPARATOR

Classic DMARDs treatment（MTX 、LEF 、HCQ 、 LEF ）

Drug: Classic DMARDs treatment group

Interventions

Infliximab group DRUG

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.

Infliximab group

Classic DMARDs treatment group DRUG

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.

Classic DMARDs treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the study protocol
• Age is from 18 to 70 years old
• To accord with the diagnostic criteria of ACR/EULAR 2010 and the course of disease is less than 2 years;
• Active RA, DAS28 score is above 5.1
• 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.

You may not qualify if:

• Received Infliximab or other biologics treatment previously;
• 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);
• Renal dysfunction, the level of serum creatinine is higher than 1.5 times of ULN;
• Receive live virus or bacterial vaccination currently or 4 weeks before recruitment into the study;
• Previously affected by tuberculosis or with positive tuberculin test result;
• 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);
• History of multiple sclerosis or other demyelinating diseases of central nervous system;
• Be allergic to experimental drug or with serious allergic constitution;
• Malignancies excluding cured skin basal cell carcinoma or carcinoma in situ of cervix;
• Systemic active infection, HIV infection or active Hepatitis B or Hepatitis B virus carriers;
• 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;

Sponsors & Collaborators

• Zhang, Xiao, M.D.: lead
• Central South University: collaborator
• Tianjin Medical University General Hospital: collaborator
• Xijing Hospital: collaborator

Study Sites (3)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

XIJING Hospital

Xi’an, Shanxi, 710032, China

Location

Tianjin medical university general hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Study Officials

• Xiao Zhang, Ph.D

  Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Zhang, Ph.D

CONTACT

+86 139 222 55387; zhangxiao20130724@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 5, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: August 5, 2013

Record last verified: 2013-07

Locations

CN (3)