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An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rituximab
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring B-cell, rituximab, Rheumatoid Arthritis

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 21 or above
  • Fulfilled the 1978 American college of Rheumatology(ACR) criteria for RA
  • Seropositive for RF with RF>20 IU/ml
  • Active disease despite treatment with at least 2 stable dose of DMARDs for at least 16 weeks, including MRX>10mg weekly
  • 4 or more swollen and/or tender joints
  • Stable dose of prednisolone<=12.5mg/day or NASID for at lease 4 weeks
  • MTX>10mg/wk and folic acid>10 mg/wk for at lease 4 weeks

Exclusion Criteria:

  • Little or no ability for self-care
  • Used a DMARD other than MTX(Leflunomide should be wash-out with cholestyramine 4 weeks prior screening)
  • Received intra-articular,intramuscular, or intravenous corticosteroids in the last 4 weeks
  • Concurrent treatment with any biologics within 8 weeks
  • Infected joint prosthesis during the previous 5 years
  • Autoimmune disease other than RA(except concurrent Sjogren's syndrome), active rheumatoid vasculitis, and history of systemic disease associated with arthritis, chronic fatigue syndrome.
  • Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months
  • Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis
  • Recurrent bacterial infections with encapsulated organisms, primary or secondary immunodeficiency
  • Active tuberculosis requiring treatment within the previous 3 years
  • Opportunistic infection such as herpes zoster within the previous 2 months
  • Any evidence of active cytomegalovirus;active Pneumocystis Jirovecl;or drug-resistant atypical mycobacterial infection
  • Known hypersensitivity to murine proteins
  • Current signs or symptoms of severe,progressive,or uncontrolled renal,hepatic,haematological,gastrointestinal,endocrine,pulmonary,cardias,neurological,or cerebral disease
  • A history of lymphoproliferative disease including lymphoma or signs suggestive of disease,such as lymphadenopathy of unusual size or location(ie,lymphadenopathy nodes,in the posterior tangle of the neck,infraclavicular epitrochlear,or periaortic areas);splenomegaly
  • Any know malignant disease except basal cell carcinoma currently or in the last 5 years

Sites / Locations

  • Department of Medicine and Therapeutics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15.

Outcomes

Primary Outcome Measures

The proportion of patients who achieved a response according to the ACR 20 response criteria at 24 weeks and 54 weeks after the initial infusion

Secondary Outcome Measures

The proportion of patients who achieved a response according to ACR50,ACR70, physician's assessment of disease activity,patient's assessment of physical function by means of a health-assessment questionnaire(HAQ),quality of life measure by SF-36

Full Information

First Posted
November 7, 2007
Last Updated
May 7, 2008
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00555542
Brief Title
An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis
Official Title
B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the effects of T cell in peripheral blood of patients with RA undergoing selective B cell depletion have not been studied. We analyze the B and T cell subsets in patients with active RA treated undergoing this form of treatment with rituximab.
Detailed Description
In this open labeled prospective study, we evaluate the therapeutic efficacy and peripheral blood cellular response of rituximab in 10 patients with active RA despite conventional DMARDs therapy. Patients are taking stable dose of methotrexate and at least 10mg folic acid per week for at least 4 weeks. Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. Premedication as standard prescription consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab. Oral prednisolone 60mg is tob e given from day 1-6 after rituximab infusion and 30mg from day 7-13. In patients who relapses following the first cycle can be repeated with the second cycle must fulfill the following conditions: Patients must have responded clinically to the first infusion with improvement Other disease modifying anti-rheumatic drugs (DMARDs) are not appropriate as determined by the investigators, either they have been on them before or are ineffective or due to side effects, Patients have a disease activity score DSA>2.6 At least 24 weeks since the first infusion Neutrophil count of >1.5 X 103/mcL The second infusion consists of rituximab 1000mg intravenous infusion on day 1 and day 15 as before and the same protocol of followed up every 4 weeks up to 52 weeks from the day of the first infusion.14 Premedication as standard prescription (consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton) 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
B-cell, rituximab, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15.
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
Mabthera
Intervention Description
Patients are taking stable dose of methotrexate and at least 10mg folic acid per week for at least 4 weeks. Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. Premedication as standard prescription consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab. Oral prednisolone 60mg is tob e given from day 1-6 after rituximab infusion and 30mg from day 7-13.
Primary Outcome Measure Information:
Title
The proportion of patients who achieved a response according to the ACR 20 response criteria at 24 weeks and 54 weeks after the initial infusion
Time Frame
wk52
Secondary Outcome Measure Information:
Title
The proportion of patients who achieved a response according to ACR50,ACR70, physician's assessment of disease activity,patient's assessment of physical function by means of a health-assessment questionnaire(HAQ),quality of life measure by SF-36
Time Frame
wk52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 21 or above Fulfilled the 1978 American college of Rheumatology(ACR) criteria for RA Seropositive for RF with RF>20 IU/ml Active disease despite treatment with at least 2 stable dose of DMARDs for at least 16 weeks, including MRX>10mg weekly 4 or more swollen and/or tender joints Stable dose of prednisolone<=12.5mg/day or NASID for at lease 4 weeks MTX>10mg/wk and folic acid>10 mg/wk for at lease 4 weeks Exclusion Criteria: Little or no ability for self-care Used a DMARD other than MTX(Leflunomide should be wash-out with cholestyramine 4 weeks prior screening) Received intra-articular,intramuscular, or intravenous corticosteroids in the last 4 weeks Concurrent treatment with any biologics within 8 weeks Infected joint prosthesis during the previous 5 years Autoimmune disease other than RA(except concurrent Sjogren's syndrome), active rheumatoid vasculitis, and history of systemic disease associated with arthritis, chronic fatigue syndrome. Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis Recurrent bacterial infections with encapsulated organisms, primary or secondary immunodeficiency Active tuberculosis requiring treatment within the previous 3 years Opportunistic infection such as herpes zoster within the previous 2 months Any evidence of active cytomegalovirus;active Pneumocystis Jirovecl;or drug-resistant atypical mycobacterial infection Known hypersensitivity to murine proteins Current signs or symptoms of severe,progressive,or uncontrolled renal,hepatic,haematological,gastrointestinal,endocrine,pulmonary,cardias,neurological,or cerebral disease A history of lymphoproliferative disease including lymphoma or signs suggestive of disease,such as lymphadenopathy of unusual size or location(ie,lymphadenopathy nodes,in the posterior tangle of the neck,infraclavicular epitrochlear,or periaortic areas);splenomegaly Any know malignant disease except basal cell carcinoma currently or in the last 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund Kwok Ming LI, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine and Therapeutics
City
Hong Kong
Country
China

12. IPD Sharing Statement

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An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

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