Rheumatoid Arthritis Clinical Trial
Official title:
Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study
Verified date | September 2012 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will examine the course of patients with progressive rheumatoid arthritis
associated interstitial lung disease (RA-ILD) treated with rituximab for safety and
progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be
assessed through patient history, physical exams and laboratory parameters.
- Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific
interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological
subtype) will be enrolled
- The study involves 12 visits over 48 weeks
- Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at
six months.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of RA according to the revised 1987 American Rheumatism Association criteria 2. Absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than UIP or NSIP, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors 3. Diagnosis of progressive interstitial pneumonia of UIP or NSIP subtype, based on the following criteria 1. Clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening. 2. Worsening as demonstrated by any one of the following within the past year: - > 10% decrease in Forced Vital Capacity (FVC) - increasing infiltrates on chest X-ray or High Resolution Computed Tomography (HRCT), or worsening dyspnea at rest or on exertion 3. Diagnosis of UIP or NSIP by either of the following: - Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP or NSIP - HRCT scan showing definite or probable UIP or NSIP AND abnormal pulmonary function tests (reduced FVC or decreased diffusing capacity of carbon monoxide (DLco) or impaired gas exchange at rest or with exercise) AND insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation 4. FVC > 50% of predicted value at Screening 5. DLco >30% of predicted value at Screening 5. No change of disease-modifying anti-rheumatic drug (DMARD) treatment within the last 3 months Exclusion Criteria: 1. History of clinically significant environmental or drug exposure known to cause pulmonary fibrosis. 2. Forced expiratory volume in one second (FEV1) FEV1/FVC ratio < 0.6 at screening (pre- or post-bronchodilator). 3. Residual volume > 120% predicted at Screening 4. Evidence of active infection 5. Any pulmonary condition other than UIP/NSIP, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year 6. History of unstable or deteriorating cardiac or neurologic disease 7. Pregnancy or lactation 8. Treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (IL1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis 9. Creatinine > 1.5 X upper limit of normal range (ULN) at Screening 10. Hematology outside of specified limits: white blood cell (WBC) < 2,500/mm^3 or absolute neutrophil count (ANC) < 1500 11. Hematocrit < 27% or > 59%, platelets < 100,000/mm^3 at screening 12. Positive hepatitis B or C serology 13. Any medical condition, which in the opinion of the site principal investigator, may be adversely affected by the participation in this study 14. History of recurrent significant infection or history of recurrent bacterial infections 15. Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening 16. Abnormal neurological examination reflective of central nervous disease, including paresis, cognitive impairment and problems with coordination 17. Current enrollment in another clinical trial 18. Fever (>99.5ยบ F) 19. History of previous rituximab administration 20. Receipt of any vaccine, particularly live viral vaccines, within 4 weeks of first study dose 21. Decreased Immunoglobulin G (IgG) and Immunoglobulin M (IgM) levels (below lower limit of normal range) 22. Present or past malignancy 23. History of severe allergic or anaphylactic reaction to administration of humanized or murine monoclonal antibodies 24. Positive human immunodeficiency virus (HIV) serology |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Eric Matteson | Genentech, Inc., National Center for Research Resources (NCRR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks | DLco is one pulmonary function measure. For DLco, worsening was defined as decrease of at least 15% and improvement was defined as increase of at least 15%. | baseline, 48 weeks | No |
Primary | Change in Forced Vital Capacity (FVC) From Baseline to 48 Weeks | FVC is one measure of pulmonary function. For FVC, worsening was defined as decrease of at least 10% and improvement was defined as increase of at least 10%. | baseline, 48 weeks | No |
Secondary | Change in Lung Fibrosis Score as Observed on High Resolution Computerized Tomography (HRCT) Scans, From Baseline to 48 Weeks | Three serial HRCT scans of each patient were scored independently and simultaneously by two core radiologists, who were blinded to the sequence in which three scans were obtained (at screening, 24 and 48 weeks). The HRCT scoring sheet scored different domains of abnormality such as, linear opacities, consolidation, ground-glass density, etc. Radiographers reported composite impression based on scoring according to worsening, no worsening or improvement of relevant domains. | baseline, 48 weeks | No |
Secondary | Assessment of RA Disease Activity Scores as Measured by the DAS28 Score at Baseline and 48 Weeks | The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health. Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6. |
baseline, 48 weeks | No |
Secondary | Change in RA Disease Activity From Baseline to 48 Weeks Using the DAS28 Score. | The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health. Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6. |
baseline, 48 weeks | No |
Secondary | Percentage of Change in Health Associated Quality of Life From Baseline to 48 Weeks | The percentage change from baseline to week 48 in a participant's perception of the impact of health on his or her quality of life was collected on the Health Assessment Questionnaire (HAQ). The HAQ measures a person's ability to function with arthritis. The questionnaire is divided into 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip and Activities) which include several questions for each category. The category score is determined by the highest score of the set of questions for each category. The disability score is determined by adding the scores for all categories and dividing by 8. The disability scale ranges from 0 (best - without any difficulty) to 3 (worst - unable to do much). | baseline, 48 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |