An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00555542

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: rituximab	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Rituximab Folic acid Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets

Further study details as provided by Chinese University of Hong Kong:

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 [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	July 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15.	Drug: rituximab 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.

Arms

Assigned Interventions

1: Experimental

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

Drug: rituximab

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.

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:
1. Patients must have responded clinically to the first infusion with improvement
2. 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,
3. Patients have a disease activity score DSA>2.6
4. At least 24 weeks since the first infusion
5. 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.

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555542

Locations

China
Department of Medicine and Therapeutics
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Edmund Kwok Ming LI, MD

Chinese University of Hong Kong

More Information

Responsible Party:	The Chinese University of Hong Kong ( Lai-Shan Tam )
Study ID Numbers:	RA-2006-005
Study First Received:	November 7, 2007
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00555542
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

B-cell
rituximab
Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Methylprednisolone
Rituximab
Joint Diseases
Arthritis, Rheumatoid
Methylprednisolone acetate
Prednisolone acetate
Rheumatic Diseases

Folic Acid
Musculoskeletal Diseases
Arthritis
Prednisolone
Connective Tissue Diseases
Methotrexate
Acetaminophen
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009