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Rheumatoid ArthritisPhase 3NCT00578565

Rituximab in Rheumatoid Arthritis Lung Disease

A Phase 3 study testing Rituximab in people with Rheumatoid Arthritis and Interstitial Pneumonia, run by Eric Matteson at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis, Interstitial Pneumonia
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
May 2007to Jun 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of RA according to the revised 1987 American Rheumatism Association criteria
  • 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
  • Diagnosis of progressive interstitial pneumonia of UIP or NSIP subtype, based on the following criteria
  • Clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening.
  • Worsening as demonstrated by any one of the following within the past year:
  • > 10% decrease in Forced Vital Capacity (FVC)
Show all 13Show fewer
  • increasing infiltrates on chest X-ray or High Resolution Computed Tomography (HRCT), or worsening dyspnea at rest or on exertion
  • 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
  • FVC > 50% of predicted value at Screening
  • DLco >30% of predicted value at Screening
  • 5. No change of disease-modifying anti-rheumatic drug (DMARD) treatment within the last 3 months

Who cannot join

  • History of clinically significant environmental or drug exposure known to cause pulmonary fibrosis.
  • Forced expiratory volume in one second (FEV1) FEV1/FVC ratio < 0.6 at screening (pre- or post-bronchodilator).
  • Residual volume > 120% predicted at Screening
  • Evidence of active infection
  • 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
  • History of unstable or deteriorating cardiac or neurologic disease
Show all 24Show fewer
  • Pregnancy or lactation
  • 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
  • Creatinine > 1.5 X upper limit of normal range (ULN) at Screening
  • Hematology outside of specified limits: white blood cell (WBC) < 2,500/mm^3 or absolute neutrophil count (ANC) < 1500
  • Hematocrit < 27% or > 59%, platelets < 100,000/mm^3 at screening
  • Positive hepatitis B or C serology
  • Any medical condition, which in the opinion of the site principal investigator, may be adversely affected by the participation in this study
  • History of recurrent significant infection or history of recurrent bacterial infections
  • 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
  • Abnormal neurological examination reflective of central nervous disease, including paresis, cognitive impairment and problems with coordination
  • Current enrollment in another clinical trial
  • Fever (>99.5º F)
  • History of previous rituximab administration
  • Receipt of any vaccine, particularly live viral vaccines, within 4 weeks of first study dose
  • Decreased Immunoglobulin G (IgG) and Immunoglobulin M (IgM) levels (below lower limit of normal range)
  • Present or past malignancy
  • History of severe allergic or anaphylactic reaction to administration of humanized or murine monoclonal antibodies
  • Positive human immunodeficiency virus (HIV) serology

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study

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.
Being tested
Rituximab
Keywords
Rheumatoid Arthritis, Interstitial Pneumonia, Rheumatology, Rituximab
Medical subject headings
Arthritis, Rheumatoid, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Rituxan, MabThera

    Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months.

Study groups in NCT00578565
Study groupRoleWhat they receive
1Experimentalopen label, all subjects will receive rituximab
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: baseline, 48 weeks

  2. 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%.

    Measured: baseline, 48 weeks

Secondary outcomes (4)

  1. 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.

    Measured: baseline, 48 weeks

  2. 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.

    Measured: baseline, 48 weeks

  3. 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.

    Measured: baseline, 48 weeks

  4. 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).

    Measured: baseline, 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00578565
Sponsor's protocol ID
06-007133
Other IDs
UL1RR024150
Status last verified
Sep 2012
First submitted
19 Dec 2007
Last updated
1 Oct 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Rheumatoid Arthritis and Interstitial Pneumonia, run by Eric Matteson at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks (time frame: baseline, 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00578565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.

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