Phase 1
Completed N=24
A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01317797 ↗Enrolled (actual)
24
Serious AEs
8.3%
Results posted
Aug 2015
Primary outcomePrimary: Number of Participants With Clinically Significant Clinical Laboratory Results — 3; 0; 1; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Clinical Laboratory Results |
3; 0; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings |
1; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Vital Signs |
3; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Pulmonary Function Tests |
0; 0; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Physical Examination Findings |
0; 0; 0 | — |
| PRIMARY Number of Participants Reporting One or More Treatment Emergent Adverse Events |
5; 4; 5 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203 |
4.98; 5.95; 4.97; 6.00 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for MT203 |
13.41; 18.76; 27.14; 49.99 | — |
| SECONDARY AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203 |
144.9; 210.9; 786.8; 1696 | — |
| SECONDARY AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203 |
832.8; 1861 | — |
| SECONDARY AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203 |
318.5; 591.9 | — |
| SECONDARY Terminal Phase Elimination Half-life (T1/2) for MT203 |
21.26; 23.68 | — |
| SECONDARY Ctrough: Maximum Observed Plasma Concentration Pre-Dose |
9.232; 14.56; 15.53; 27.28; 20.27; 36.88 | — |
| SECONDARY Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma |
0.00; -0.86; 0.67; 3.00; 0.86; 0.00 | — |
| SECONDARY Change From Baseline in MT203/GM-CSF Complexes in Plasma |
30.9; 12.7; -0.2; 210.6; 186.1; -0.6 | — |
| SECONDARY Number of Participants With Anti-MT203 Antibodies |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR 20) Response |
50.0; 14.3; 11.1; 50.0; 57.1; 33.3 | — |
| SECONDARY Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR) |
-0.473; -0.310; -0.344; -0.798; -0.995; -0.383 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
- 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
- Age ≥ 18 years at Screening
- Body weight at least 50 kg at Screening; BMI: ≥ 18.0 and ≤ 30.0 kg/m2 at Screening
- Negative tuberculosis test at Screening
- 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
- Participation in another clinical trial or previous dosing in this trial
- Use of specified medications within certain timeframes or use of certain comedications
- History or presence of specified diseases
- Drug abuse
- Certain laboratory parameters outside a specified range
- Donation of blood
- Relevant decrease in lung function
- Infections, frequent or chronic infections, herpes zoster
- Females: positive pregnancy test
- Presence of history of tuberculosis
- History of malignancy
Data sourced from ClinicalTrials.gov (NCT01317797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.