A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: namilumab (MT203); Placebo
Intervention description: administered three times, subcutaneous in the abdomen; administered three times, subcutaneous in the abdomen
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; MT203; Human IgG1 monoclonal antibody; GM-CSF monoclonal antibody

Summary:

      The purpose of this trial is primarily to investigate the safety and tolerability of repeated
      subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
      Furthermore, the amount of MT203 in the blood will be measured and it will be investigated
      how the body responds to MT203 treatment and if MT203 is effective in the treatment of
      rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Out-patients with active rheumatoid arthritis (RA), according to the ACR 1987 revised
             criteria, with low to moderate disease activity (DAS28-ESR ≥ 2.6 and ≤ 5.1)

          2. Patients must be on stable doses of methotrexate (MTX) ≥ 7.5 and ≤ 25 mg/week for at
             least 12 weeks before the first injection, with appropriate folic acid supplementation

          3. Age ≥ 18 years at Screening

          4. Body weight at least 50 kg at Screening; BMI: ≥ 18.0 and ≤ 30.0 kg/m2 at Screening

          5. Negative tuberculosis test at Screening

          6. Heterosexually active male and female patients of childbearing potential are obliged
             to follow whatever contraceptive and / or breastfeeding restrictions may be required
             for their concomitant medication(s), including methotrexate.

        In addition, heterosexually active male and female patients of childbearing potential are
        required to use effective double-method contraception (one hormonal contraceptive or
        intrauterine device and one other additional contraceptive method) for 1 month before the
        first administration of the IMP, during the course of the trial, and for 6 month after the
        last injection of MT203.

        No special requirements are made for female patients proven to be post-menopausal (at least
        2 years after last menstrual period and FSH ≥ 40IU/L), surgically sterilized or
        hysterectomized. Likewise no special requirements for heterosexually active male who are
        surgical sterilized.

        Pregnant or lactating female patients have to be excluded.

        Exclusion Criteria:

          1. Participation in another clinical trial or previous dosing in this trial

          2. Use of specified medications within certain timeframes or use of certain comedications

          3. History or presence of specified diseases

          4. Drug abuse

          5. Certain laboratory parameters outside a specified range

          6. Donation of blood

          7. Relevant decrease in lung function

          8. Infections, frequent or chronic infections, herpes zoster

          9. Females: positive pregnancy test

         10. Presence of history of tuberculosis

         11. History of malignancy