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

July 10, 2008 updated by: Merrimack Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
      • Montgomery, Alabama, United States, 36111
        • Montgomery Rheumatology Associates
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Arizona Arthritis Research, PLC
      • Phoenix, Arizona, United States, 85012
        • ArthroCare, Arthritis Care and Research, Inc.
      • Scottsdale, Arizona, United States, 85251
        • Radiant Research
    • California
      • Santa Maria, California, United States, 93454
        • Arthritis Medical Center of the Central Coast
      • Upland, California, United States, 91786
        • Boling Clinical Trials
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • New England Research Associates
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis and Rheumatic Disease Specialties
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Ormond Beach, Florida, United States, 32174
        • International Medical Research
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Research Center
      • South Miami, Florida, United States, 33143
        • Center for Arthritis and Rheumatic Diseases
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Coeur D'Alene Arthritis Clinic
    • Illinois
      • Morton Grove, Illinois, United States, 60016
        • Illinois Bone and Joint Institute
      • Springfield, Illinois, United States, 62704
        • The Arthritis Center
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Rheumatology Associates, Pc
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Wichita Clinic
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Rx Trials, Inc.
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Arthritis Center of Nebraska
    • Nevada
      • Reno, Nevada, United States, 89502
        • Arthritis Center of Reno
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Arthritis, Osteoporosis & Musculoskeletal Disease Center
    • New York
      • Syracuse, New York, United States, 13210
        • Arthritis Health Associates
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Rheumatology and Osteoporosis Research Associates, Inc
      • Charlotte, North Carolina, United States, 28210
        • Arthritis Clinic and Carolina Bone and Joint PA
      • Raleigh, North Carolina, United States, 27609
        • CARE Center
      • Raleigh, North Carolina, United States, 27609
        • North Carolina Arthritis and Allergy Care Center
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Veterans Administration Research Services
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Willow Grove, Pennsylvania, United States, 19090
        • Rheumatic Disease Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • The Arthritis Group
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Rheumatology Research
      • Houston, Texas, United States, 77074
        • Houston Institute for Clinical Research
      • Waco, Texas, United States, 76708
        • Arthritis And Osteoporosis Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Division of Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
To evaluate the safety and tolerability of 3 different dose levels of MM-093

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merrimack Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MM-093-01-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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