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Rheumatoid ArthritisPhase 2NCT00425932

Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis

A Phase 2 study testing Rituximab in people with Rheumatoid Arthritis, run by Gaylis, Norman B., M.D. at 6 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

The purpose of this study is to further investigate rituximab in the treatment of rheumatoid arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to improve the evaluation of treatments. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis
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
60 participants
Where
6 sitesUnited States
Study dates
Feb 2007to Nov 2012
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Able and willing to give written informed consent
  • Age 18-80 years
  • Must have active rheumatoid arthritis for at least 12 weeks, but no more than 5 years.
  • Must be receiving treatment on an outpatient basis
  • Must have > 8 tender and swollen joints
  • Must have negative serum pregnancy test
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  • Must have an inadequate response to MTX
  • Must have elevated serology parameters
  • Must have Positive RF or anti-CCP antibody, or radiographic evidence of at least one joint with definite erosion attributable to RA.
  • Stable use of Corticosteroids is permitted
  • Stable use of NSAIDs is permitted

Who cannot join

  • History of or current inflammatory joint disease
  • Functional class IV
  • Any surgical procedure within 12 weeks
  • Lack of peripheral venous access.
  • Pregnancy or breast feeding.
  • Significant cardiac or pulmonary disease.
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  • Evidence of significant uncontrolled concomitant disease
  • Positive HIV
  • Known active infection of any kind
  • History of deep space/tissue infection
  • History of recurrent significant infection
  • Concomitant malignancies or previous malignancies
  • Any neurological, vascular or systemic disorder
  • History of drug, alcohol, or chemical abuse
  • Inability to comply with study and follow-up procedures
  • History of a severe allergic or anaphylactic reaction to a biologic agent
  • Previous treatment with more than one biologic agent for RA. Patients must not have received a biologic agent within 2 months prior to the Baseline visit, except for etanercept, abatacept and anakinra for which a one month washout prior to Baseline visit is acceptable
  • Previous treatment with an anti-alpha 4 integrin antibody or co-stimulation modulator.
  • Previous treatment with any cell depleting therapies.
  • Treatment with any investigational agent within 28 days
  • Receipt of a live/attenuated vaccine within 28 days
  • Ongoing use of high dose steroids (>10mg/day)
  • Inra-articular or parental glucocorticoids within 4 weeks prior to baseline.
  • Intolerance or contraindications to i.v. glucocorticoids.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Guillermo Valenzuela MD

    Fort Lauderdale, Florida, 33324

  • Drs. Charles Kahn and Wayne Riskin

    Hollywood, Florida, 33021

  • Arhtritis & Rheumatic Disease Specialties

    Miami, Florida, 33180

  • McBride Clinic Orthopedic Center

    Oklahoma City, Oklahoma, 73103

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • Arthritis and Rheumatology Clinics of Kansas

    Wichita, Kansas, 67220

Other trials in United States

About this study

Official title: Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis

The purpose of this study is to further investigate rituximab in the treatment of rheumatoid arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to improve the evaluation of treatments.

Read the detailed description

Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin's B cell lymphoma (a type of cancer) and for certain patients with rheumatoid arthritis (RA) by the Food and Drug Administration (FDA). To date, more than 1000 subjects with rheumatoid arthritis have received rituximab in clinical studies.

Magnetic resonance imaging (MRI) is a modern and sensitive method of looking at joints in people with rheumatoid arthritis. It uses a magnetic field to create an image. The MRI takes an image in 3 dimensions and this provides a better picture for a physician to see more details.

There are two treatment groups in this study with equal numbers of patients assigned to each group. All the patients will receive their baseline Methotrexate and two intravenous infusions 2 weeks apart of one of the following:

  • 1000 mg rituximab or
  • placebo. Patients outcomes will be compared between the 2 groups. After week 24 (open label phase), the patients will receive rituximab if rheumatoid arthritis remains active.

All the patients will have MRI of their dominant hand and wrist with and without gadolinium performed at baseline, 12, 24 and 48 weeks on 1.5 Tesla MRI . Some patients will also have additional MRI of the same hand and wrist without gadolinium at the same time points on 0.2 Tesla MRI. Comparison of the images from the two machines will be performed.

Various blood biomarkers will also be examined, compared between the 2 treatment groups and correlated with the MRI results.

Being tested
Rituximab
Keywords
Magnetic Resonance Imaging, Rituximab, Low Field MRI, Biomarkers
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • RituximabBiological

    Also called Rituxan

    At Week 24 or any time up to Week 48 if the Patient DAS 28 > 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.

Study groups in NCT00425932
Study groupRoleWhat they receive
Rituximab/PlaceboNo interventionPatients will be randomized at Baseline to either Placebo or Rituximab. At Week 24 and up to Week 48 if patient DAS28 score is >2.6, patient will be retreated with open label Rituximab.
Open LabelActive comparatorAt Week 24 or any time up to Week 48 if the Patient DAS 28 > 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.
Receives: Biological: Rituximab

What is being measured

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

  1. The primary endpoint fo the trial is change in 1.5 Tesla MRI erosion score (RAMRIS system) from baseline to Week 24.

    Measured: 24 weeks

Secondary outcomes (9)

  1. Change from Baseline in 1.5 Tesla MRI synovitis score (RAMRIS system) at Week 12.

    Measured: 12 weeks

  2. Change from Baseline in 1.5 Tesla MRI bone edema and total score (RAMRIS system) at Week 24.

    Measured: 24 weeks

  3. Change from Baseline in 1.5 Tesla MRI bone edema, bone erosion and total score (RAMRIS system) at Week 12 and Week 48.

    Measured: 12 and 48 weeks

  4. Proportion of patients at Week 48 without new bone erosions on 1.5 Tesla MRI.

    Measured: 48 weeks

  5. Change from baseline in total Genant modified Sharp score on conventional radiographs at Week 24 and 48.

    Measured: 24 and 48 weeks

  6. Change in Disease Activity Score (DAS 28) from Baseline to Week 24 and 48.

    Measured: 24 and 48 weeks

  7. ACR remission and responder rates (20%, 50%, &)%) at Week 24 and 48.

    Measured: 24 and 48 weeks

  8. Change from Baseline in functional assessments according to the HAQ scores at 24 and 48 Weeks.

    Measured: 24 and 48 weeks

  9. Difference between relative results from conventional high-field strength 1.5 Tesla MRI and 0.2 Tesla dedicated extremity MRI in detection and grading of bone erosions, bone edema, and synovitis at Baseline and in Week 12,24, and 48 (C-scan validation).

    Measured: 12, 24 and 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 posted24 Jan 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionNov 2011
  4. Study completionNov 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425932
Sponsor's protocol ID
U3900s
Status last verified
Aug 2013
First submitted
22 Jan 2007
Last updated
22 Aug 2013
Results posted
No

Publications

  • Peterfy CG, Olech E, DiCarlo JC, Merrill JT, Countryman PJ, Gaylis NB. Monitoring cartilage loss in the hands and wrists in rheumatoid arthritis with magnetic resonance imaging in a multi-center clinical trial: IMPRESS (NCT00425932). Arthritis Res Ther. 2013 Mar 20;15(2):R44. doi: 10.1186/ar4202.

    PubMed 23514433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab in people with Rheumatoid Arthritis, run by Gaylis, Norman B., M.D. at 6 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 11 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 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary endpoint fo the trial is change in 1.5 Tesla MRI erosion score (RAMRIS system) from baseline to Week 24. (time frame: 24 weeks). 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 NCT00425932, which also lists 1 linked publication.

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 22 Aug 2013.

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