Conditions: Rheumatoid Arthritis
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of namilumab in combination with existing methotrexate (MTX) therapy over 24 weeks in participants with moderate to severe early rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX alone.

Detailed description:
The drug being investigated in this study is namilumab for the treatment of moderate to severe Rheumatoid Arthritis (RA). This study will evaluate the efficacy and safety of namilumab in participants diagnosed with RA within 6 months and insufficiently controlled by methotrexate (MTX) alone.

The study will enroll approximately 36 patients, who will be randomly assigned in a 2:1 ratio to the following open label treatment groups:

* Namilumab 150 mg + MTX + folic acid
* Adalimumab 40 mg + MTX + folic acid

Imaging techniques, including Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), will be used to measure changes in the dominant hand and the wrist.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is a maximum of 42 weeks, including follow-up period. Participants will make 16 visits to the site and will be followed up by telephone twice after end of treatment.

A strategic decision was made to stop the study on 18 December 2015 in order to fully understand the data from the psoriasis study (ClinicalTrials.gov Identifier:NCT02129777) and wait for the results of the formal proof of concept study (ClinicalTrials.gov Identifier: (NCT02379091) in participants with rheumatoid arthritis.

Arms:
arm 1: Adalimumab 40 mg, subcutaneous (SC) injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication. arm 2: Namilumab 150\*2 mg, SC injection at Week 0 followed by 150 mg, SC injections at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication.

Interventions: intervention 1: Namilumab intervention 2: Adalimumab intervention 3: Methotrexate intervention 4: Folic Acid
Intervention descriptions: intervention 1: Namilumab injection intervention 2: Adalimumab SC injection intervention 3: Methotrexate tablet intervention 4: Folic Acid Tablet

Protocol document: