RheumatoId Arthritis Clinical Trial
Official title:
Bone Resorption, Osteoclastogenesis and Adalimumab
Broca II is the prolongation of the original study name BROCA. In BROCA study, only 25 patients participated and it was not enough to concluded clearly our hypothesis.
Osteoclasts (OC) are clearly involved in joint destruction in Rheumatoid Arthritis (RA), as
shown by clinical and experimental data. Tumor Necrosis Factor Alpha (TNF-alpha), a major
pathologic mediator in RA, may induce bone resorption either directly, stimulating
osteoclastogenesis or indirectly, by influencing receptor activator of nuclear factor kappa-B
ligand (RANKL), osteoprotegerin (OPG) and prostaglandin production by osteoblasts. Anti-TNF
agents reduce bone destruction in RA but their effects on osteoclast biology in patients with
RA are little known.
The original BROCA study, which included a cohort of 25 RA patients, aimed to study the
effect of treatment with Adalimumab on times zero, 3 and 6 months on the following
osteoclastic parameters: 1) the number of osteoclast precursor (CD14+) cells in the
peripheral blood, 2) the number of osteoclasts generated in vitro, and 3) the amount of bone
resorption in vitro before, 3 and 6 months after treatment with Adalimumab. The secondary
outcomes were 1) The effect of treatment with Adalimumab on disease activity score defined as
a DAS28 score (Disease Activity Score, 2) The effect of treatment with Adalimumab (also name:
Humira) on change in functional status by the health assessment questionnaire (HAQ), and 3)
Parallel in vitro differentiation assays (number of osteoclasts generated and amount of bone
resorption) in the presence of exogenous Adalimumab in the concentration range found in the
plasma of treated patients to detect a direct effect of the medication in vitro in
osteoclastogenesis.
The results showed that treatment with Adalimumab induced a statistically significant
reduction in the clinical scores DAS28 and HAQ, as has been shown by many clinical studies .
Even though no statistically significant effect of the treatment was found on the number of
osteoclast precursors, the number of osteoclasts generated in vitro or the surface of bone
resorption in vitro, there was a clear trend towards a decrease in the last two parameters.
We believe this lack of statistical significance is due to a type II error, a consequence of
the much higher variance of the primary parameter (number of in vitro-generated osteoclasts)
in the patient cohort than we could foresee from the initial data from normal donors.
Moreover, there was a statistically significant correlation (p=0.416, linear regression)
between the difference in the number of osteoclasts in time zero and six months and the
difference in the HAQ score, which not only supports the hypothesis that the treatment with
Adalimumab may be associated with a reduction in the number of osteoclasts but also suggests
that this reduction may be associated with a better response to the treatment. The general
objective of the proposed prolongation of the BROCA study is to verify these two working
hypothesis.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |