Lead Investigator: José da Silva, Centro Hospitalar e Universitário de Coimbra
Title of Proposal Research: Comparing the prevalence of Boolean-based remission based on 3 versus 4 variables and their association with radiographic outcomes in rheumatoid arthritis using data from Tofacitinib studies
Vivli Data Request: 8684
Funding Source: A research grant will be assessed by Pfizer
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Rheumatoid Arthritis (RA) is a disease in which the immune system wrongly attacks the joints, leading to pain and swelling and severe limitations of daily activities. It affects about 7 in every 1000 people globally. Doctors use various methods to determine if a patient’s RA is improving and adjust medications based on this. One method is the Patient Global Assessment (PGA), where patients rate how they feel on a scale of 0 (very bad) to 100 (very well). However, some doctors believe this isn’t the most accurate way to inform about RA improvement and could influence medication choices in ways that aren’t best for the patient. Because of this, our group has done previous studies comparing the incorporation of PGA together with three other measures [the number of swollen and painful joints in an examination of 28 joints in the shoulders, knees, arms and hands called swollen joint count 28 (SJC28) and tender joint count 28 (TJC28), and a blood measure of C-Reactive Protein (CRP) which indicates inflammation], defined as 4Variable remission, against a 3Variable definition (i.e. SJC28, TJC28, and CRP; PGA not included).
To manage RA, medicines like Tofacitinib slow down the immune system. Tofacitinib, taken as a pill, seems to be quicker and more effective at reducing RA symptoms compared to older treatments, which are injections called “biologics.”
One way to see if medicines are working is to examine X-rays of patients’ hands and feet for signs of “bone damage.” Think of it like looking at stones outdoors. Over time, stones can get small holes or scratches from weather elements. Similarly, RA can cause such ‘erosions’ in joints. Fewer erosions in X-rays indicate that the medication is effectively preserving the joints, just as undamaged stones indicate minimal weather wear. In RA’s case, inflammation is like damaging weather.
Our study will examine data from past research where patients took Tofacitinib and biologics. We’ll focus on seeing how many had minimal erosions over two years. Specifically, we’ll compare two groups: 1) those with high PGA but low inflammation and 2) those with very low PGA and low inflammation. Our aim is to determine if results vary between Tofacitinib and biological treatments.
Requested Studies:
PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE NAVIE PATIENTS WITH RHEUMATOID ARTHRITIS
Data Contributor: Pfizer Inc.
Study ID: NCT01039688
A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS
Data Contributor: Pfizer Inc.
Study ID: NCT00413699
AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAIVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS
Data Contributor: Pfizer Inc.
Study ID: NCT01164579
A LONG-TERM, OPEN-LABEL STUDY OF CP-690,550 TO CONFIRM THE SAFETY FOLLOWING LONG TERM ADMINISTRATION OF CP-690,550 IN THE TREATMENT OF RHEUMATOID ARTHRITIS
Data Contributor: Pfizer Inc.
Study ID: NCT00661661
Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Data Contributor: Pfizer Inc.
Study ID: NCT00847613
Sponsor ID: A3921044