Method for treating joint damage

a joint damage and joint technology, applied in the field of joint damage treatment, can solve the problems of joint damage and damag, poor long-term prognosis of ra, and loss of daily function, and achieve the effect of reducing joint damag

Inactive Publication Date: 2009-09-24
F HOFFMANN LA ROCHE & CO AG +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0055]In another embodiment of the invention, a method is provided for treating joint damage in a subject comprising administering a CD20 antibody to the subject, and giving the subject, at least about 52 weeks after the administration, a radiographic test that measures a reduction in the joint damage as compared to baseline prior to the administration, wherein the amount of CD20 antibody administered is effective in achieving a reduction in the joint damage.
[0056]In a still furth

Problems solved by technology

Joint Destruction and Damage
It is a systemic inflammatory disease characterized by chronic inflammation in the synovial membrane of affected joints, which ultimately leads to loss of daily function due to chronic pain and fatigue.
The majority of patients also experience progressive deterioration of cartilage and bone in the affected joints, which may eventually lead to permanent disability.
The long-term prognosis of RA is poor, with approximately 50% of patients experiencing significant functional disability within 10 years from the time of diagnosis.
Such diseases are accompanied by bone loss around affected joints due to increased osteoclastic resorption.
There is loss of articular cartilage and the formation of bony erosions.
Ultimately, the integrity of the joint structure is compromised, producing disability.
However, the progression rates in individuals within the treatment and control groups overlap to a considerable extent; therefore, despite significant differences between treatment groups, these data cannot be used to estimate the probability that a patient who is starting a treatment will have a favorable outcome with respect to progression of radiographic damage.
Determining whether there has been increased structural damage in an individual patient during the interval between paired radiographs obta

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Efficacy and Safety of Rituximab in Patients with an Inadequate Response or Lack of Tolerance to Prior Anti-TNF Therapy

[0351]This is a Phase III randomized, double-blind, parallel-group multicenter clinical trial, called: Randomised Evaluation oFLong-term Efficacy of Rituximab in RA (REFLEX). The study design is shown in FIG. 1.

The objectives of this study were:[0352]To determine the efficacy and safety of rituximab when used in combination with methotrexate (MTX) in 517 patients with active rheumatoid arthritis who have an inadequate response to one or more anti-TNF therapies.[0353]To explore the pharmacokinetics and pharmacodynamics of rituximab in this patient population (e.g. extent of duration of B-cell depletion and effects on immunoglobulins and rheumatoid factor).

The outcomes of this study were:[0354]Primary endpoint[0355]The proportion of patients with an ACR20 response at Week 24.[0356]Secondary Endpoints[0357]Proportion of patients with ACR50 and ACR70 responses at Week 2...

example 2

Rituximab in RA: Phase III Program

[0417]An important outcome to assess in RA includes the inhibition of progression of structural joint damage and the improvement in physical function. This outcome is particularly important for patients who have recently been diagnosed with RA, since early impact on these has potentially higher long-term benefit. Genovese et al., Arthritis Rheum. 46: 1443-1450 (2002). A population of early RA patients would therefore be an appropriate population to study for these important outcomes.

[0418]With regard to a suitable control treatment for these patients, the current gold standard therapy for early RA is MTX. Consequently, selecting a population of MTX-naïve patients and comparing rituximab plus MTX to MTX alone provides a comparison of this new treatment approach against the current gold standard for these patients.

[0419]This study is a randomized Phase III controlled soluble-blind, parallel-group multicenter study to evaluate the safety and efficacy o...

example 3

Study of Efficacy of Retreatment with Rituximab in Patients with Rheumatoid Arthritis

[0579]This example describes a phase III randomized double-blind, placebo-controlled multicenter study of retreatment with rituximab in subjects with RA receiving background methotrexate.

[0580]The primary objective of this study is to evaluate the efficacy of retreatment with rituximab in subjects with active RA who are receiving MTX and who have had an inadequate response to TNF inhibitors.

[0581]The secondary objectives of this study are as follows:[0582]To evaluate the safety of retreatment with rituximab in subjects with active RA who are receiving MTX and who have had an inadequate response to TNF inhibitors[0583]To evaluate the safety of rituximab in subjects with active RA who are receiving MTX and who have had an inadequate response to TNF inhibitors

[0584]This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab ...

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Abstract

Methods of treating joint damage in a subject eligible for treatment are provided involving administering an antagonist that binds to a B-cell surface marker, such as CD20 antibody, to the subject in an amount effective to slow progression of the joint damage as measured by radiography. Further provided are articles of manufacture useful for such methods.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a National Stage application filed under 35 USC § 371 of PCT Application No. PCT / US2006 / 044290, filed Nov. 14, 2006, which claims the benefit of priority under 35 U.S.C. §119(e) of provisional application Nos. 60 / 864,463, filed Nov. 6, 2006, and 60 / 737,291, filed Nov. 15, 2005. The contents of each application listed in this paragraph are fully incorporated by reference herein.FIELD OF THE INVENTION[0002]The present invention concerns methods for treating joint damage in subjects suffering therefrom.BACKGROUND OF THE INVENTIONJoint Destruction and Damage[0003]Inflammatory arthritis is a prominent clinical manifestation in diverse autoimmune disorders including rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), Sjögren's syndrome and polymyositis. Most of these patients develop joint deformities on physical examination but typically only RA and PsA patients manifest bone erosions o...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61P19/02A61P37/00A61B10/00
CPCA61K2039/505C07K16/2896C07K2317/565C07K2317/56C07K2317/24A61K47/6849A61P1/04A61P17/06A61P19/00A61P19/02A61P29/00A61P37/00A61P37/06A61P43/00A61K9/0053A61K9/20A61K39/395C07K16/28A61K31/519A61K39/3955A61K45/06C07K16/2887C07K2317/76
Inventor TOTORITIS, MARKSHAW, TIMOTHY MARKAGARWAL, SUNILYOCUM, DAVIDKELMAN, ARIELLA
Owner F HOFFMANN LA ROCHE & CO AG
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