A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00458146
First received: April 5, 2007
Last updated: March 24, 2008
Last verified: March 2008
  Purpose

The purpose of this study is to determine whether MM-093 is safe and effective in the treatment of RA.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: MM-093
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 60mg of MM-093 Versus Placebo in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Evaluate the efficacy of MM-093 using ACR20 response rate [ Time Frame: After three months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the efficacy of MM-093 using DAS-28 and EULAR [ Time Frame: After three months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2007
Arms Assigned Interventions
Experimental: 1
MM-093
Drug: MM-093
60mg MM-093/week as a subcutaneous injection for 3 months
Placebo Comparator: 2
Placebo
Drug: MM-093
60mg MM-093/week as a subcutaneous injection for 3 months

Detailed Description:

To evaluate the safety and tolerability of 60 mg of MM-093 in patients who have active RA despite MTX background therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet American College of Rheumatology (ACR) criteria for RA.
  • Have active RA consisting of > or equal to 6 tender joints and > or equal to 6 swollen joints and one of the following:CRP or ESR levels of ULN
  • Have an ACR functional class of I-III.
  • Have had RA for at least 6 months.
  • Had disease onset at > 16 years of age.
  • Aged 18 - 80 years.
  • Currently being treated with a stable, well tolerated weekly dose of MTX between 10-25 mg for at least 6 consecutive prior to screening visit.
  • Currently being treated with folic/folinic acid in conjunction with their MTX treatment.

(Note: Patients may begin folic/folinic acid treatment after their screening visit, but must remain on stable dose for two weeks before undergoing the Day 1 assessments.)

  • Willing to remain on a constant, weekly dose of MTX and folic/folinic acid through out 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.
  • Women of childbearing potential must use a medically acceptable means of birth control in an effective manner and agree to continue its use during the study and for 4 weeks after the last dose of study drug. Women who have had a complete surgical hysterectomy or are postmenopausal (absence of menstrual period for at least one year or > 52 years old) are exempt from this requirement. Medically acceptable forms of birth control include oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed more than 1 year before screening), or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
  • 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.
  • Able to store patient kit/cooler containing drug in a refrigerator at home.

Exclusion Criteria:

  • Patient will be excluded if any of the following prior medications are currently being used or have used within the designated time interval before the screening visit:

    1. Any B - cell or antibody depleting therapy , including plasmaphoresis or Prosorba columns (6 months)
    2. Leflunomide, Adalimumab (Humira)(3 months)
    3. Investigational biologics (2 months)
    4. Infliximab (Remicade) (2 months)
    5. Cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, D-penicillamine, tacrolimus (6 weeks)
    6. Investigational small molecules (e.g. NSAIDS or Cox-2 inhibitors)(4 weeks)
    7. Use more than 10mg/day of prednisone or equivalent (4 weeks)
    8. Bolus intramuscular/intravenous (IM/IV) treatment with corticosteroids (>20 mg prednisone or equivalent)(4 weeks)
    9. Intra-articular corticosteroid injection (4 weeks)
    10. Etanercept (Enbrel) (4 weeks)
    11. Anakinra (Kineret) (2 weeks)
    12. Use of more than one NSAID (current)
    13. Dose of NSAID greater than maximum recommended dose in the product information (current)
  • Significant concurrent medical diseases including:

    1. Cancer, or a history of cancer (other than successfully resected cutaneous basal and squamous cell carcinoma) within 5 years before the screening visit.
    2. 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-related severe, potentially life threatening AE.
    3. Significant ongoing infection requiring systemic antibiotic, antifungal, antiviral, or anti-myobacterial 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/mm^3 [SI units: < 3.0 x 10^9/L)
  • Thrombocytopenia or thrombocytosis (platelets > 125,000/mm^3 or > 1,000,000/mm^3 [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 aminotransfersate [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 the screening visit.
  • Scheduled elective surgery during the 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. (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 grade 2 or above clinical finding or laboratory result).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458146

Locations
United States, Alabama
Montgomery Rheumatology Associates
Montgomery, Alabama, United States, 36111
United States, Arizona
East Valley Rheumatology & Osteoporosis
Gilbert, Arizona, United States, 85234
Radiant Research
Scottsdale, Arizona, United States, 85251
United States, California
Arthritis Medical Center of the Central Coast
Santa Maria, California, United States, 93454
United States, Colorado
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Connecticut
New England Research Associates
Trumbull, Connecticut, United States, 06611
United States, Florida
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Paddock Park Clinical Research
Ocala, Florida, United States, 34474
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, United States, 34684
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239
United States, Illinois
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
United States, Kansas
Wichita Clinic
Wichita, Kansas, United States, 67208
United States, Nebraska
Arthritis Center of Nebraska
Lincoln, Nebraska, United States, 68516
United States, Nevada
Arthritis Center of Reno
Reno, Nevada, United States, 89502
United States, North Carolina
Arthritis Center and Carolina Bone and Joint
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
East Pennsylvania Rheumatology Association
Bethlehem, Pennsylvania, United States, 18015
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Rheumatology and Internal Medicine
Amarillo, Texas, United States, 79106
United States, Utah
University of Utah Division of Rheumatology
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00458146     History of Changes
Other Study ID Numbers: MM-093-01-201
Study First Received: April 5, 2007
Last Updated: March 24, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014