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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Namilumab injection
Adalimumab SC injection
Methotrexate tablet
Unnamed facility
Pardubice, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Tallinn, Estonia
Unnamed facility
Tartu, Estonia
Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24
A Magnetic Resonance Imaging (MRI) of Metacarpophalangeal (MCP) and Wrist of the dominant hand was performed at the baseline and at week 24. Change from the Baseline was assessed according to the Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials RA-MRI scoring (OMERACT RAMRIS) Standard. RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis is scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema is scored 0 (normal) to 69 (maximum articular bone involvement). Erosion is scored from 0 (normal) to 230 (maximum erosion of articular bone). Total RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number = increasing severity.
Time frame: Baseline and Week 24
Change From Baseline in Dynamic Contrast-enhanced - Magnetic Resonance Imaging (DCE-MRI) Parameters at Week 24
DCE-MRI was used to measure synovial vascular perfusion. The change from baseline in DCE-MRI parameters of synovial vascular perfusion at Week 24 were measured.
Time frame: Baseline and Week 24
Number of Participants Who Achieved Remission at Week 24
Remission is defined as the number of participants who achieved Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) score \<2.6. The DAS28-CRP is a composite measure of inflammation in rheumatoid arthritis (RA) and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Folic Acid Tablet
Unnamed facility
Moscow, Russia
Unnamed facility
Yaroslavl, Russia
Unnamed facility
Santiago de Compostela, La Coruna, Spain
Unnamed facility
Fuenlabrada, Madrid, Spain
Unnamed facility
A Coruña, Spain
Unnamed facility
Madrid, Spain
...and 3 more locations
Time frame: Week 24
Number of Participants Who Achieved Low Disease Activity at Week 24
Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) low disease activity is defined as a score \<3.2. The DAS28-CRP is a composite measure of inflammation in RA and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
Time frame: Week 24
Number of Participants Who Achieved ACR 20, 50, and 70 at Week 24
The American College of Rheumatology (ACR) 20 is composite index of improvement in RA proposed by the ACR. ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.
Time frame: Week 24
Change From Baseline in DAS28-CRP Score
The DAS28-CRP is a composite measure of inflammation in RA and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
Time frame: Baseline Up to Week 42