A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis

NCT ID: NCT01317797

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-08-31

Brief 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.

Detailed Description

The trial medication will be administered at 2 dose levels as subcutaneous injections. Each patient will receive three injections in total. The trial duration consists of a screening period (28 - 2 days prior to the first injection) and a treatment and observation period (4 months). The trial requires approximately 20 visits at the study site.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Namilumab 150 mg

Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.

Group Type: EXPERIMENTAL

namilumab (MT203)

Intervention Type: DRUG

administered three times, subcutaneous in the abdomen

Namilumab 300 mg

Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.

Group Type: EXPERIMENTAL

namilumab (MT203)

Intervention Type: DRUG

administered three times, subcutaneous in the abdomen

Placebo

Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

administered three times, subcutaneous in the abdomen

Interventions

Placebo

administered three times, subcutaneous in the abdomen

Intervention Type: DRUG

namilumab (MT203)

administered three times, subcutaneous in the abdomen

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nycomed Investigational Site

Sofia, , Bulgaria

Nycomed Investigational Site

Leids, , Netherlands

Countries

Bulgaria; Netherlands

References

Huizinga TW, Batalov A, Stoilov R, Lloyd E, Wagner T, Saurigny D, Souberbielle B, Esfandiari E. Phase 1b randomized, double-blind study of namilumab, an anti-granulocyte macrophage colony-stimulating factor monoclonal antibody, in mild-to-moderate rheumatoid arthritis. Arthritis Res Ther. 2017 Mar 9;19(1):53. doi: 10.1186/s13075-017-1267-3.

Reference Type: DERIVED

PMID: 28274253 (View on PubMed)

Other Identifiers

2010-018502-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1137-3923

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL33507.058.10

Identifier Type: REGISTRY

Identifier Source: secondary_id

M1-1188-002-EM

Identifier Type: -

Identifier Source: org_study_id