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Center for Global Research Data

Justification of PROMIS (FACIT) Fatigue Short Form 10a scale for FDA Drug Development Tool Qualification in Rheumatoid Arthritis

Lead Investigator: John Peipert, Northwestern University
Title of Proposal Research: Justification of PROMIS (FACIT) Fatigue Short Form 10a scale for FDA Drug Development Tool Qualification in Rheumatoid Arthritisistologic Predictors of Endoscopic Healing in Crohn’s Disease
Vivli Data Request: 5897
Funding Source: The source of funding for this project is the Rheumatoid Arthritis Working Group of the Critical Path Institute (C-Path).
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis and is associated with fluctuating debilitating symptoms that confer considerable decrements to patients’ longevity and quality of life. Patient and clinician input reveal that fatigue has been identified as a common, persistent, and disabling symptom in RA, and a high priority for RA patients seeking treatment. RA patients not only consider fatigue as one of the most important aspects of their disease experience, but as an important outcome when evaluating the effectiveness of interventions. Research examining the fatigue experience of RA patients suggests that RA-associated fatigue differs from “normal” fatigue, impacts multiple domains of patients’ lives, and is under-recognized by clinicians. Patient-reported outcome (PRO) measures serve as the best method for assessing symptoms like fatigue, as its severity and impact are best known by the patient. Given the importance patients place on fatigue and its resolution as part of remission, the persistence of fatigue despite well-controlled disease activity as defined by traditional indicators, broader inclusion of fatigue measures is needed in RA clinical trials in order to better understand patients’ responses to treatment. This includes determination of whether interventions can provide overall benefit to patients above and beyond the existing indicators for disease progression, symptom maintenance, and clinical remission. Precise and valid measurement of fatigue is required to fully evaluate the effects of RA interventions in clinical trials. Clinical Outcome Assessments (COAs) measure a patient’s symptoms, mental state, or the effects of a disease or condition on how the patient functions, and can be used to determine whether or not a drug has been demonstrated to provide treatment benefit.

Our research team, led by Dr. Cella at Northwestern University has extensive history working in the measurement of fatigue in RA. For example, the application of the FACIT Fatigue (Yellen, Cella, Webster, Blendowski, & Kaplan, 1997) expanded to non-cancer populations, including RA. In 2005, Cella and colleagues (Cella et al., 2005) evaluated the psychometric performance of the FACIT Fatigue using data from the Safety Trial of Adalimumab in Rheumatoid Arthritis. And in 2016, we developed the PROMIS Short Form Fatigue 10a (Kaiser, Shaunfield, Clayman, Ruderman, & Cella, 2016).

Requested Studies:

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
Sponsor: Pfizer
Study ID: NCT00847613
Sponsor ID: A3921044

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis
Sponsor: Pfizer
Study ID: NCT00814307
Sponsor ID: A3921045

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
Sponsor: Pfizer
Study ID: NCT00960440
Sponsor ID: A3921032

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
Sponsor: Pfizer
Study ID: NCT01039688
Sponsor ID: A3921069

A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Data Contributor: Pfizer Inc.
Study ID: NCT00853385
Sponsor ID: NCT00853385

A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
Data Contributor: Pfizer Inc.
Study ID: NCT00856544
Sponsor ID: NCT00856544

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate (ORAL STRATEGY)
Data Contributor: Pfizer Inc.
Study ID: NCT02187055
Sponsor ID: NCT02187055

Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
Data Contributor: Pfizer Inc.
Study ID: NCT00413699
Sponsor ID: NCT00413699