RA rheumatoid arthritis
Conditions
Interventions
Repeated subcutaneous injections of MT203 or placebo, every 14 days (in total 3
doses per patient).
Sponsors
Takeda
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Out-patients with active RA with low to moderate disease activity (DAS28 >= 2.6 and = 7.5 and = 18 years at screening. 4. Body weight >= 50 kg at screening; BMI >= 18.0 and
Exclusion criteria
Exclusion criteria: 1. The use of any medication, including local injections with gold or corticosteroids, over-the-counter medication and prescription anti-rheumatic naturopathic medicines/phytopharmaca ("herbs") with immunomodulatory effect, except for the allowed concomitant medication, within 2 weeks, or within less than 10 times the half-life of the respective drug, or within the duration of its pharmacodynamic effect before the first injection (whichever is longer), as well as the anticipated use of disallowed concomitant medication between the first injection and EoT/ET visit. 2. Previous use of any GM-CSF treatment and/or any treatment antagonising GM-CSF or its receptor at any time in the past. 3. The use of biological agents (as experimental therapy or not) within (whichever is longer): - 10 times the respective half-life before the first injection of trial medication. - the continuation of the pharmacodynamic effects of the respective agent before the first injection of trial medication. - 3 months before the first injection of trial medication in case of TNF inhibitors. - 12 months for any cell depleting therapies (after B-cell depleting therapy, B-cells must have returned to normal values before screening). 4. The use of the oral DMARD leflunomide within 12 weeks before the first injection of trial medication, or within 4 weeks before first injection of trial medication if supportive oral cholestyramine (>= 8 g/tid) or charcoal (>=50g/qds) washout treatment is/was given. 5. Chronic use of prophylactic or suppressive antibiotic, antifungal or antiviral agents. 6. The use of intra-muscular, intravenous or intra-articular corticosteroids within 4 weeks before the first injection of trial medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not applicable: this is a mainly a safety and efficacy study (phase Ib), please refer to the study objectives. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable; see primary endpoints. | — |
Countries
Netherlands
Outcome results
None listed