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Rheumatoid ArthritisPhase 2NCT00105976

Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)

A Phase 2 study testing MM-093 in people with Rheumatoid Arthritis, run by Merrimack Pharmaceuticals at 38 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 clinical study is to see if an experimental drug, called MM-093, is safe and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered version of a naturally occurring protein called alpha fetoprotein (AFP). 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?
MM-093
How many people
260 participants
Where
38 sitesUnited States
Study dates
Feb 2005to not given
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

  • Aged 18-80 years
  • Meet ACR (American College of Rheumatology) criteria for RA
  • Have active RA consisting of 6 or more swollen and 6 or more tender joints
  • Have RA for at least 6 months
  • Had disease onset after 16 years old
  • Currently being treated with a stable, well-tolerated dose of MTX (10 to 25 mg) given once weekly for at least 6 consecutive weeks prior to the screening visit
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  • Currently being treated with folic acid
  • Willing to remain on a constant, once-weekly dose of MTX and folic/folinic acid throughout the duration of the study.
  • Understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed.
  • Be able and willing to comply with study visits and procedures per protocol.
  • Sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 4 weeks after the last dose of study drug.
  • Women of childbearing potential must use a medically acceptable means of birth control during the study and for 4 weeks after the last dose
  • Must be able to store study drug in a refrigerator at home

Who cannot join

  • Use of any B-cell depleting therapy in the last 6 months
  • Use of Leflunomide or Humira in the last 3 months
  • Use of any investigational drug or biologic agent in the last 2 months
  • Use of Remicade in the last 2 months
  • Use of cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, D-penicillamine or tacrolimus within the last 6 weeks
  • Use of more than 10 mg/day of prednisone or equivalent in the last 4 weeks
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  • Use of intra-articular corticosteroid injection in the last 4 weeks
  • Use of a bolus IM/IV (intramuscular/intravenous) treatment with corticosteroids (>20 mg prednisone or equivalent) in the last 4 weeks
  • Use of Enbrel in the last 4 weeks
  • Use of Kineret in the last 2 weeks
  • Current use of more than 1 NSAID (non-steroidal anti-inflammatory drug) or dose of NSAID greater than the maximum recommended dose in the product information
  • Cancer, or a history of cancer (other than successfully resected cutaneous basal and squamous cell carcinoma) within 5 years before the screening visit.
  • Any condition for which participation in this study is judged by the physician to be detrimental to the patient, such as history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric disease, or a DMARD (Disease-Modifying Anti-Rheumatic Drug)-related severe, potentially life-threatening AE (Adverse Event).
  • Significant ongoing infection requiring systemic antibiotic, antifungal, antiviral, or any anti-mycobacterial therapy.
  • Autoimmune or connective tissue disorder other than rheumatoid arthritis (e.g. systemic lupus erythematosis, scleroderma or psoriatic arthritis).
  • Grade 2 or above leukopenia (i.e. white blood cells < 3000/mm3 [SI units: < 3.0 x 10^9/L]).
  • Thrombocytopenia or thrombocytosis (platelets < 125,000/mm3 or ≥ 1,000,000/mm3 [SI units: < 125 x 10^9/L or ≥ 1,000 x 10^9/L]), respectively.
  • Grade 2 or above liver function abnormality (i.e. total bilirubin > 1.5 x the upper limit of normal; or aspartate aminotransferase [AST/SGOT] or alanine aminotransferase [ALT/SGPT] > 2.5 x upper limit of normal).
  • Renal disease (including serum creatinine level > 1.5 x the upper limit of normal).
  • Any history of immunodeficiency syndromes or infection with human immunodeficiency virus (HIV), or a history of hepatitis C or chronic hepatitis B.
  • Pregnant or breastfeeding women or women planning to become pregnant during the study or within 4 weeks after the last dose of study drug.
  • Any major surgery, including joint surgery, within 3 months before screening visit.
  • Scheduled elective surgery during study participation.
  • Participated in any previous clinical trial using MM-093 or have any prior exposure to MM-093.
  • History of severe hypersensitivity to goat, sheep or cow milk or products derived from goat, sheep or cow milk (patients who are lactose intolerant are not excluded).
  • Any other condition that the investigator feels would jeopardize the integrity of the study (e.g. a CTCAE [Common Terminology Criteria for Adverse Events] grade 2 or above clinical finding or laboratory result).

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Asheville Rheumatology and Osteoporosis Research Associates, Inc

    Asheville, North Carolina, 28801

  • Austin Rheumatology Research

    Austin, Texas, 78705

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • University of Alabama

    Birmingham, Alabama, 35294

  • New England Research Associates

    Bridgeport, Connecticut, 06606

  • Arthritis Clinic and Carolina Bone and Joint PA

    Charlotte, North Carolina, 28210

  • Veterans Administration Research Services

    Cincinnati, Ohio, 45220

  • Coeur d'Alene Arthritis Clinic

    Coeur d'Alene, Idaho, 83814

  • Rx Trials, Inc.

    Columbia, Maryland, 21045

  • Arthritis, Osteoporosis & Musculoskeletal Disease Center

    Concord, New Hampshire, 03301

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Houston Institute for Clinical Research

    Houston, Texas, 77074

  • Rheumatology Associates, PC

    Indianapolis, Indiana, 46260

  • Arthritis Center of Nebraska

    Lincoln, Nebraska, 68516

  • The Arthritis Group

    Memphis, Tennessee, 38104

  • Montgomery Rheumatology Associates

    Montgomery, Alabama, 36111

  • Illinois Bone and Joint Institute

    Morton Grove, Illinois, 60016

  • Renstar Medical Research

    Ocala, Florida, 34471

  • International Medical Research

    Ormond Beach, Florida, 32174

  • Arizona Arthritis Research, PLC

    Paradise Valley, Arizona, 85253

  • ArthroCare, Arthritis Care and Research, Inc.

    Phoenix, Arizona, 85012

  • CARE Center

    Raleigh, North Carolina, 27609

  • North Carolina Arthritis and Allergy Care Center

    Raleigh, North Carolina, 27609

  • Arthritis Center of Reno

    Reno, Nevada, 89502

  • University of Utah Division of Rheumatology

    Salt Lake City, Utah, 84132

  • Arthritis Medical Center of the Central Coast

    Santa Maria, California, 93454

  • Sarasota Arthritis Research Center

    Sarasota, Florida, 34239

  • Radiant Research

    Scottsdale, Arizona, 85251

  • Center for Arthritis and Rheumatic Diseases

    South Miami, Florida, 33143

  • The Arthritis Center

    Springfield, Illinois, 62704

  • Arthritis Health Associates

    Syracuse, New York, 13210

  • Boling Clinical Trials

    Upland, California, 91786

  • Deerbrook Medical Associates

    Vernon Hills, Illinois, 60061

  • Arthritis and Osteoporosis Clinic

    Waco, Texas, 76708

  • Wichita Clinic

    Wichita, Kansas, 67208

  • Rheumatic Disease Associates

    Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Dose Levels (2.5, 7.5 and 20 mg) of MM-093 in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate

The purpose of this clinical study is to see if an experimental drug, called MM-093, is safe and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the mother and the fetus are much higher than normal. It has been observed that women with RA (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third trimester. At this time, the levels of AFP in the blood of the mother and fetus are the highest. This observation led researchers to begin examining AFP as a possible treatment for RA.

Being tested
MM-093
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • MM-093Drug

What is being measured

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

  1. To evaluate the efficacy of 3 different dose levels of MM-093 as measured by the percentage of patients achieving an ACR20 response after 24 weeks compared to placebo

  2. To evaluate the safety and tolerability of 3 different dose levels of MM-093

Timeline

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

  1. First posted21 Mar 2005 (estimated)
  2. Study startFeb 2005

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
Parallel groups
Masking
Double blind
Enrolment
260 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00105976
Sponsor's protocol ID
MM-093-01-200
Status last verified
Jul 2008
First submitted
18 Mar 2005
Last updated
11 Jul 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MM-093 in people with Rheumatoid Arthritis, run by Merrimack Pharmaceuticals at 38 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 26 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 11 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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?

To evaluate the efficacy of 3 different dose levels of MM-093 as measured by the percentage of patients achieving an ACR20 response after 24 weeks compared to placebo. 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 NCT00105976.

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 11 Jul 2008.

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