This PDF is the current document as it appeared on Public Inspection on 06/26/2017 at 08:45 am.
Agency for Healthcare Research and Quality (AHRQ), HHS.
Request for supplemental evidence and data submissions.
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Drug Therapy for Early Rheumatoid Arthritis in Adults—An Update, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Submission Deadline on or before July 27, 2017.
Email submissions: SEADS@epc-src.org.
Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, Portland, OR 97239.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Ryan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: SEADS@epc-src.org.End Further Info End Preamble Start Supplemental Information
AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Drug Therapy for Early Rheumatoid Arthritis in Adults—An Update.
The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Drug Therapy for Early Rheumatoid Arthritis in Adults—An Update, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2475.
This is to notify the public that the EPC Program would find the following information on Drug Therapy for Early Rheumatoid Arthritis in Adults—An Update helpful:
A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.
For completed studies that do not have results on ClinicalTrials.gov, Start Printed Page 29084please provide a summary, including the following elements: Study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.
A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.
Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.
Your contribution will be very beneficial to the EPC Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program Web site and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.
The Key Questions
Key Question (KQ) 1
For patients with early Rheumatoid Arthritis (RA), do drug therapies differ in their ability to reduce disease activity, slow or limit the progression of radiographic joint damage, or induce remission?
For patients with early RA, do drug therapies differ in their ability to improve patient-reported symptoms, functional capacity, or quality of life?
For patients with early RA, do drug therapies differ in harms, tolerability, patient adherence, or adverse effects?
What are the comparative benefits and harms of drug therapies for early RA in subgroups of patients based on disease activity, prior therapy, demographics (e.g., women in their childbearing years), concomitant therapies, and presence of other serious conditions?
Contextual Questions (CQs)
Contextual questions are not systematically reviewed and use a “best evidence” approach. Information about the contextual questions may be included as part of the introduction or discussion section and related as appropriate to the Systematic Review.
Does treatment of early RA improve disease trajectory and disease outcomes compared with the trajectory or outcomes of treatment of established RA?
What barriers prevent individuals with early RA from obtaining access to indicated drug therapies?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
I. All KQs: Adult outpatients ages 19 or older with an early RA diagnosis, defined as 1 year or less from disease diagnosis; we will include studies with mixed populations if >50% of study populations had an early RA diagnosis
II. KQ 4 only: Subpopulations by age, sex/gender, race/ethnicity, disease activity, prior therapies, concomitant therapies, and other serious conditions
Adolescents and adult patients with disease greater than 1 year from diagnosis.
I. FDA approved
A. Corticosteroids: Methylprednisolone, prednisone, prednisolone
B. csDMARDs: Hydroxychloroquine, leflunomide, methotrexate, sulfasalazine
C. TNF biologics: Adalimumab, certolizumab pegol, etanercept, golimumab, infliximab
D. Non-TNF biologics: Abatacept, rituximab, tocilizumab
E. tsDMARDs: Tofacitinib
F. Biosimilars: Adalimumab-atto, infliximab-dyyb, infliximab-abda, etanercept-szzs
II. Under review by FDA
A. Non-TNF biologics: Sarilumab, sirukumab
Anakinra is excluded because, although it is approved for RA, clinically it is not used anymore for this population.
I. For head-to-head RCTs, head-to-head nRCTs, and prospective, controlled cohort studies (all KQs): Any active intervention listed above
II. For additional observational studies of harms (i.e., overall [KQ 3] and among subgroups [KQ 4]: Any active intervention listed above or no comparator (e.g., postmarketing surveillance study of an active intervention with no comparison group)
III. For double-blinded, placebo-controlled trials for network meta-analysis (all KQs): Placebo
All other comparisons, including active interventions not listed above.
I. KQs 1, 4: Disease activity, radiographic joint damage, remission
II. KQs 2, 4: Functional capacity, quality of life, patient-reported symptoms
III. KQs 3, 4: Overall risk of harms, overall discontinuation, discontinuation because of adverse effects, risk of serious adverse effects, specific adverse effects, patient adherence
All other outcomes not listed.
All KQs: At least 3 months of treatment.
<3 months treatment.Start Printed Page 29085
All KQs: Outpatients.
All KQs: Any geographic area.
I. For all KQs (i.e., benefits and harms overall [KQs 1, 2, 3] and among subgroups [KQ 4]), we will include head-to head RCTs and nRCTs; prospective, controlled cohort studies (N ≥ 100); double-blinded, placebo-controlled trials for network meta-analysis; and SRs for identification of additional references only.
II. For studies of harms (i.e., overall [KQ 3] and among subgroups [KQ 4]), we will also include any other observational study (e.g., cohort, case-control, large case series, post marketing surveillance) (N ≥ 100).
All other designs not listed.
All KQs: English.
Languages other than English.Start Signature
Sharon B. Arnold,
[FR Doc. 2017-13395 Filed 6-26-17; 8:45 am]
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