Lead Investigator: Jose Antonio Pereira da Silva, Universidade de Coimbra, Portugal
Title of Proposal Research: Long-term predictive value of patient global assessment regarding radiographic damage and physical function in patients with Rheumatoid Arthritis: individual patient data meta-analysis
Vivli Data Request: 5985, 5327
Funding Source: None
Potential Conflicts of Interest: JAPS reports a research grant from Pfizer and Abvvie, and speaker fees from Pfizer, AbbVie, Roche, Lilly, Novartis. These potential conflicts will be disclosed in all papers resulting from this project.
Summary of the Proposed Research:
The treatment of Rheumatoid Arthritis (RA) has improved remarkably over recent years, due to not only the development of new therapies but also novel treatment strategies. Among these, the Treat-to-Target (T2T) recommendation epitomizes the consensual concept that disease treatment should aim at achieving, as early and consistently as possible, a target of level of remission, or at least low disease activity. To assess if the target is achieved or not physicians use composite indices that include different variables. The most common variables used in these indices (or remission definitions) are: number of tender (TJC28) and swollen joint counts (SJC28), a inflammatory parameter (blood analysis) and a patient reported outcome (PRO) designed by “Patient Global Assessment” (PGA). In this PGA the patients is questioned “Considering all the ways your arthritis has affected you, how do you feel your arthritis is today?” and asked to rate it from 0 to 100.
This study is designed to clarify whether PGA should or not be used to guide immunosuppressive therapy and evaluate its results in RA.
To this purpose we will test the relationship between two different definitions of disease remission and long-term outcomes in terms of structural damage (X-Rays) and function. The states of remission will be categorized as follows:
-“4v-Remission”: the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Boolean-based definition: TJC28<=1, SJC28<=1, C-reactive protein (CRP) in mg/dl<=1, and PGA<=1/10.
-“3v-Remission”: as above, excluding PGA.
Analyses will also specifically address the outcomes of patients that achieve 3v but not 4v-Remission (i.e. distinguished by only PGA). To achieve this goal on the most robust way we are trying to pool together individual level patient data from as many randomized clinical trials (RCT) as possible, including studies from different pharmaceutical companies.
A number of secondary outcomes will also be addressed including whether the relationship between remission states (i.e. 3v and 4v-remission) and long-term outcome is influenced by treatment arm and other factors (e.g. age, gender, co-medication, disease duration, other), over time.
Expected result include the demonstration that the value and efficacy of available biologic therapies is actually higher than previously acknowledged and also that PGA should not be included in the definition of the target for immunosuppressive therapy. This does not mean that the patient perspective should be disregarded. By the contrary, we support that, once disease control is achieved, adjunctive therapy of a different nature (pharmacological and/or nonpharmacological) should be guided by patients’ perspective, but maybe using more informative tools than PGA.
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Sponsor ID: DE013
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Sponsor ID: C87050
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Sponsor ID: C87027
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Sponsor ID: C87028
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Sponsor ID: C87051
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Sponsor: Pfizer Inc.
Study ID: NCT00393471
A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Sponsor: Pfizer Inc.
Study ID: NCT00195494
(Note: Additional studies added as part of Data Request 5985)
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Sponsor ID: WA17823
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Sponsor ID: NA25220
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Sponsor ID: WA19926
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Sponsor ID: WA17531
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Study ID: NCT00299104
Sponsor ID: U3373g