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Rheumatoid ArthritisPhase 2NCT00458146

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

A Phase 2 study testing MM-093 in people with Rheumatoid Arthritis, run by Merrimack Pharmaceuticals at 20 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 determine whether MM-093 is safe and effective in the treatment of RA. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
20 sitesUnited States
Study dates
Feb 2007to 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

  • 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.
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  • 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.

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Rheumatology and Internal Medicine

    Amarillo, Texas, 79106

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • East Pennsylvania Rheumatology Association

    Bethlehem, Pennsylvania, 18015

  • Arthritis Center and Carolina Bone and Joint

    Charlotte, North Carolina, 28210

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • East Valley Rheumatology & Osteoporosis

    Gilbert, Arizona, 85234

  • Arthritis Center of Nebraska

    Lincoln, Nebraska, 68516

  • Montgomery Rheumatology Associates

    Montgomery, Alabama, 36111

  • Illinois Bone & Joint Institute

    Morton Grove, Illinois, 60053

  • Paddock Park Clinical Research

    Ocala, Florida, 34474

  • Arthritis Research of Florida, Inc.

    Palm Harbor, Florida, 34684

  • 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

  • New England Research Associates

    Trumbull, Connecticut, 06611

  • Wichita Clinic

    Wichita, Kansas, 67208

Other trials in United States

About this study

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

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

Read the detailed description

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

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

    60mg MM-093/week as a subcutaneous injection for 3 months

Study groups in NCT00458146
Study groupRoleWhat they receive
1ExperimentalMM-093
Receives: Drug: MM-093
2Placebo comparatorPlacebo
Receives: Drug: MM-093

What is being measured

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

  1. Evaluate the efficacy of MM-093 using ACR20 response rate

    Measured: After three months of treatment

Secondary outcomes (1)

  1. Evaluate the efficacy of MM-093 using DAS-28 and EULAR

    Measured: After three months of treatment

Timeline

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

  1. First posted9 Apr 2007 (estimated)
  2. Study startFeb 2007

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00458146
Sponsor's protocol ID
MM-093-01-201
Status last verified
Mar 2008
First submitted
5 Apr 2007
Last updated
27 Mar 2008
Results posted
No
Data monitoring committee
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 20 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 15 inclusion and 30 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 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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. Some participants in this study may receive a placebo. 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?

Evaluate the efficacy of MM-093 using ACR20 response rate (time frame: After three months of treatment). 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 NCT00458146.

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 27 Mar 2008.

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