Date: Wed, 18 Aug 1999 00:08:42 EDT

From:

March 20, 1992

To: File

From: Mary Ann woodbury

Status: U of MI Case-control Study Revisions

This memo provides a synopsis of two telephone calls.

1.Thursday, March 19, 1991 Telephone call from Brian Keroack, M.D.

Rheumatology Fellow

The outcome of the meeting of Carol Burns, Brian Keroack, M.D. and Maureen Mayes, M.D. was as follows. A positive ANA will not be used as a part of the case definition for UCTD, as it is most likely associated with an undiagnosed SLE case. Rather that create a case definition for UCTD, the U of MI will most likely use a case definition which is based on the one published by Alarcon et al, J. Rheum 18(9).:1332, 1991. Copy attached.

2.Friday, March 20, 1992 Telephone call to David Schottenfeld, M.D.Principal Investigator

A proposal and budget to speed up the U of MI study will be submitted to Dow Corning, if possible, next week.

A letter facsimile will be sent to Dow Coming as soon as possible, requesting official sanction from DC to provide additional resources of approximately $65,000 in incentive money for hospitals participating in the study. Healthcare Knowledge Resources believes that offering an incentive will significantly speed up the process and lead to a better participation rate. The proposal will be to pay each hospital $5 per record abstracted plus $10 For a patient contact, if one is made. U of MI is asking for immediate approval as they are ready to send the letters out to the hospitals right now.

A second proposal for expansion of the study into Ohio will be submitted to DC 4 to 6 weeks from now.

U of MI will provide a revised estimate of the relative risk that their study may detect for systemic scleroderma based on various assumptions. Assumptions will vary on

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the estimated incidence of systemic scleroderma, beta and a two sided versusa one sided test.

The U of MI can expect to receive a letter requesting that their researchproposal, abstract forms, and pretest questionnaire be provided to the FDA.The letter making this request will most likely come from DC.

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3/19/92 11:20 313-763-1253 RHEUMATOLOGY DC CORP MEDICAL

Undifferentiated Connective Tissue Disease Critera:

Adapted from Alarcon et al J. Rheum 18(9):1331 1991

UCTD defined as follows: At least one of the three MAJOR criteria

(1) Raynauds

(2) Isolated Kerato conjectivitis Scicca

(3) Unexplained Polyarthritis (including possible and probable RA) and (4) at least 3 other criteria that could not be attributed to other disease proceses including:

Raynauds

Myalgia

Rash

Kerato-conjunctivitis

Pleuritis

Pericarditis

CNS symptoms

Pulmonary symtoms

Peripheral neuropathy elevated ESR

False + VDRL

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