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Last Loaded on Web: Monday, April 01, 2013
Adis Clinical Trials Insight presents highly structured records of key papers, published in more than 1,300 international medical and biomedical journals, papers presented at 100 meetings and clinical data from media releases and relevant company and trial registry Web sites on drugs, drug therapy, adverse drug reactions, and pharmacoeconomics. Document types include Best Evidence, Supporting Evidence, and Ongoing Trial records.
Summaries are presented in a highly structured and consistent format to provide a clear definition of the study and results. Drug regimens, results and side effects, etc., are presented in easy-to- read tables. Adis Clinical Trials Insight also provides an evaluation score for clinical trials (applicable to Best Evidence records only) as an independent guide to the quality of the trial, design, and reporting.
Files 173 & 973 include all record types. Files 373 & 873 include the former Summary and Citation records. Files 873 and 973 are subscriber files.
USE FILE 173to search for information on drugs, drug therapy, adverse drug reactions, and pharmacoeconomics. USE AC= and CC=to create a set of records by WHO or EphMRA category SELECT AC=L01ASELECT UD=YYYYMMDDto create a set of New, Significantly Modified, and Modified records in a given update USE DT=ONGOING TRIALto isolate records that profile a trial USE ST=to see the various Study Status options of Ongoing Trial records EXPAND ST=USE SK=to search Endpoints and biomarkers SELECT SK=BIOMARK?MAP LK in File 107to find related records SELECT LK=019461;MAP LK;B107;EXS /p> |
| ACRONYM | CATEGORY NAME |
|---|---|
| ADIS | Adis Files |
| DRUGDEV | Drug Development Pipeline |
| DRUGECON | Pharmacoeconomics |
| PHARM | Pharmacology |
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ADIS Clinical Trials Insight is produced by Wolters Kluwer Pharma Solutions. Questions concerning file content should be directed to: Sarah Schweer Client Services Department 770 Township Line Road, Suite 300 Yardley, PA 19067
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Wolters Kluwer Pharma Solutions Client Services Department 250 Waterloo Road London, SE1 8RD United Kingdom
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For Dialog's Redistribution and Archive Policy, enter HELP ERA online. The following terms and conditions also apply.
Database copyrighted by Adis Data Information BV. Data may not be duplicated in hard copy or machine-readable format without written permission of Adis Data Information BV.
If data is to be distributed under Dialog's Redistribution and Archiving (ERA) policy, distribution is restricted to the company and geographical boundaries of the country where the data was downloaded. Data which has been downloaded under this provision may not be sold or resold to a third party outside the company organization.
| DIALOG(R)File 173:Adis Clinical Trials Insight | |
| (c) 2009 Wolters Kluwer Pharma Sol. All rts reserv | |
| AA= | 0000104589 801040717 |
| /TI | ADIS TITLE: |
| Methotrexate: therapeutic use; Rheumatoid arthritis; In patients with | |
| undifferentiated arthritis: PROMPT study | |
| /TI | ORIGINAL TITLE: |
| Probable rheumatoid arthritis methotrexate versus placebo therapy | |
| (PROMPT)-study: indications for a window of opportunity in the treatment | |
| of patients with undifferentiated arthritis. | |
| CD= | ADIS CREATION DATE: 7 July 2006 (20060707) |
| PD=,PY= | PUBLICATION DATE: 1 July 2006 ( 20060701 ) |
| AU= | AUTHOR(S): |
| Van Dongen H; Van Aken J; Lard LR; Ronday HK; Speyer I; Westedt ML; | |
| Allaart CF; Toes REM; Breedveld FC; Huizinga TWJ | |
| CS= | CORPORATE SOURCE: |
| Leiden University Medical Center, Leiden, The Netherlands | |
| JN=,SN=,SO= | JOURNAL NAME: |
| Annals of the Rheumatic Diseases (Ann-Rheum-Dis) 0003-4967 65 (Suppl. | |
| II): 54 (plus oral presentation) abstr. OP0001, Jul 2006 | |
| AS= | THERAPEUTIC AREA: |
| Rheumatic Disease | |
| DT= | DOCUMENT TYPE: Best Evidence |
| LA= | LANGUAGE: English |
| MT= | MEETING NAME: |
| Annual European Congress of Rheumatology (2006 : June 2006 : Amsterdam, | |
| Netherlands) | |
| NS= | STUDY NAME: |
| - Probable RA: Methotrexate vs Placebo Therapy (PROMPT) | |
| CI= | CLINICAL RELEVANCE: |
| A | |
| /EV,OT= | OUTCOME: |
| Efficacy: Methotrexate > Placebo | |
| /EV,SM= | STUDY MESSAGES: |
| Efficacy: Methotrexate is beneficial in patients with undifferentiated | |
| arthritis fulfilling the criteria for probable rheumatoid arthritis. | |
| /EV,RH= | RESULTS HIGHLIGHTS: |
| Efficacy: Methotrexate was beneficial in patients with undifferentiated | |
| arthritis fulfilling the criteria for probable rheumatoid arthritis. | |
| Rheumatoid arthritis was diagnosed in 20% of methotrexate recipients | |
| compared with 29% in the placebo group. In patients with erosive | |
| disease, the rate of radiographic progression was significantly lower | |
| in methotrexate than placebo recipients (p<0.05). | |
| /EV,AE= | ADIS ASSESSMENT: |
| Adis Comment: Methotrexate, an antimetabolite agent, is well established | |
| in the treatment of malignancies and autoimmune diseases such as | |
| rheumatoid arthritis. It acts specifically by inhibiting folic acid | |
| metabolism. In rheumatoid arthritis, the action of methotrexate | |
| appears to involve interference in immune function which may play a | |
| role in the pathogenesis of the disease.Professor Tom Huizinga, one | |
| of the study investigators, comments that the PROMPT data are | |
| "excellent news" as they show "that methotrexate appears to delay or | |
| even prevent progression to rheumatoid arthritis." Another PROMPT | |
| investigator, Henrike Van Dongen, says that "one of the most | |
| interesting findings from the study was that the patients who | |
| benefited the most were the ones showing a positive anti-CCP test, | |
| which would in general terms show that a patient has a very high | |
| likelihood of developing full-blown rheumatoid arthritis; however, | |
| this study indicates that the progression to a full-blown disease | |
| amongst these patients could be influenced." This study was published | |
| as an abstract in the proceedings of the 2006 Annual European | |
| Congress of Rheumatology (EULAR) held in Amsterdam, The Netherlands, | |
| in June 2006. Additional information used in this assessment was | |
| presented orally at the conference. | |
| /TX | STUDY PURPOSE: |
| This study investigated the benefits of methotrexate treatment in | |
| patients with undifferentiated arthritis fulfilling the 1958 American | |
| College of Rheumatology (ACR) criteria for probable rheumatoid | |
| arthritis. The primary endpoints were the rates of rheumatoid arthritis | |
| (according to the 1987 ACR criteria) and radiographic progression | |
| (according to the Sharp/van der Heijde scores). | |
| /TX | AUTHOR COMMENT: |
| "Patients with UA (undifferentiated arthritis) fulfilling the ACR 1958 | |
| criteria for probable RA (rheumatoid arthritis) benefit from treatment | |
| with MTX (methotrexate). Fewer patients fulfil the ACR 1987 criteria for | |
| RA and they do so at a later time point. MTX treatment also resulted in | |
| less progression in radiographic joint damage. Anti-CCP (citrullinated | |
| peptide)-positive patients seem to benefit most from treatment with MTX, | |
| which indicates the existence of a window of opportunity in | |
| anti-CCP-positive arthritic patients to influence the disease | |
| progression into full-blown RA. This is the first RCT (randomised | |
| controlled trial) that demonstrates the existence of such a window of | |
| opportunity." | |
| /TX | STUDY DETAILS: |
| SI= | Design: double-blind, multicentre, randomised |
| Control: placebo comparison, baseline comparison | |
| PS= | Phase: III |
| SK= | Endpoints: Kaplan-Meier-survival-rate, Disease-progression-rate, |
| Radiographic-outcomes, Remission-rate, | |
| American-College-of-Rheumatology-criteria, Time-to-disease-occurrence | |
| Name: Probable RA: Methotrexate vs Placebo Therapy (PROMPT) | |
| SUBJECT DETAILS: | |
| Type: patients | |
| No: 110 | |
| Age: mean 51 years | |
| Sex: not stated | |
| Location: Unknown | |
| Disease: Rheumatoid-arthritis | |
| Patient Inclusion: undifferentiated arthritis fulfilling the 1958 ACR | |
| criteria for probable rheumatoid arthritis, duration of symptoms <=2 | |
| years | |
| PK= | Patient Age Keywords: adult |
| /TX | TREATMENTS: |
| Methotrexate | |
| -------------------------------------------------------------------- | |
| Drug/Treatment Dose Route Frequency Duration | |
| -------------------------------------------------------------------- | |
| Methotrexate 15-30 mg/week PO 1/week >12 months | |
| -------------------------------------------------------------------- | |
| Placebo | |
| Placebo | |
| RESULTS: | |
| -------------------------------------------------------------------- | |
| Outcomes (% patients) Placebo Methotrexate | |
| -------------------------------------------------------------------- | |
| Rheumatoid arthritis 29 20 | |
| Remission 11 18 | |
| -------------------------------------------------------------------- | |
| ATC CODES: | |
| AC= | WHO: L01BA01 |
| CC= | EPhMRA: L01B |
| /DE, /DU, /DI | DESCRIPTORS: |
| DRUG: Methotrexate, therapeutic use | |
| DISEASE: Rheumatoid arthritis, treatment | |
| LK= | R&D INSIGHT LINK(S): |
| 020557; 021340 |
| SEARCH SUFFIX |
DISPLAY CODE |
FIELD NAME |
INDEXING |
SELECT EXAMPLES |
|---|---|---|---|---|
| None | None | All Basic Index Fields | Word | S STAGE(W)I(W)HYPERTENSION |
| /CR | CR | References1,3 | Word | S ELI(W)LILLY/CR |
| /DE | DE | Descriptor | Word & Phrase |
S CANDESARTAN(W)CILEXETIL/DE S HYPERTENSION(L)PREVENTION/DE |
| /DI | DI | Disease Descriptors | Phrase | S RHEUMATOID ARTHRITIS/DI |
| /DU | DU | Drug Descriptors | Phrase & Word & Phrase |
S METHOTREXATE(L)THERAPEUTIC?/DU S METHOTREXATE/DU S METHOTREXATE(L)THERAPEUTIC USE/DI |
| /EV | EV | Evaluation | Word | S PLACEBO(W)RECIPIENTS/EV |
| /NA | DG | Drug Name1,2 | Phrase | S CANDESARTAN-CILEXETIL/NA |
| /OD | OD | Other Descriptors1 | Word & Phrase |
S RESEARCH(1W)DEVELOPMENT/OD S RESEARCH "AND" DEVELOP?/OD |
| /PR | PR | Pharmacoeconomic Desciptors | Word & Phrase |
S DECISION(W)ANALYSIS/PR S MANAGED CARE/PR |
| /SE | SE | Side Effects4 | Word | S NEUROLOGICAL/SE |
| /TI | TI | Adis Title and Original Title | Word | S METHOTREXATE(S)RHEUMATOID/TI |
| /TX | AF | Adverse Effects1 | Word | S CLINICAL(W)CURE/TX |
| /TX | CA | Case Details4 | Word | S TREATING(W)GABHS/TX |
| /TX | CT | Author Comment1 | Word | S PATIENTS(1W)UA/TX |
| /TX | OC | Ongoing Trials Comment1,3 | Word | S ARTHRITIS(2N)METHOTREXATE/TX |
| /TX | PU | Study Purpose1 | Word | S BENEFITS(1W)METHOTREXATE/TX |
| /TX | RE | Results1 | Word | S ARTHRITIS(1W)REMISSION/TX |
| /TX | SD | Study Details1 | Word | S DOUBLE(W)BLIND/TX |
| /TX | SJ | Subject Details1 | Word | S UNDIFFERENTIATED(W)ARTHRI?/TX |
| /TX | TR | Treatments1 | Word | S METHOTREXATE/TX |
| /TX | TX | Text | Word | S CITRULLINATED(W)PEPTIDE/TX |
2 Use the UDF (NA or DG) or KWIC to display.
3 Only found in DT=ONGOING TRIAL records.
| SEARCH PREFIX |
DISPLAY CODE |
FIELD NAME |
INDEXING |
SELECT EXAMPLES |
|---|---|---|---|---|
| AA= | AA | Adis Accession Number | Phrase | S AA= 801040717 |
| AC= | AC | ATC WHO Codes1 | Phrase | S AC= L01BA01 |
| AE= | AE | Adis Assessment5 | Word & Phrase |
S AE=(PHARMACOLOGICAL(W) INTERVEN?) S AE=THIS STUDY WAS PRESENTED? |
| AS= | AS | Therapeutic Area | Phrase | S AS=RHEUMATIC DISEASE |
| AU= | AU | Author | Phrase | S AU=VAN DONGEN H |
| None | AZ | DIALOG Accession Number | ||
| CC= | CC | EphMRA Codes1 | Phrase | S CC=L01B |
| CD= | CD | Adis Creation Date1,6 | Phrase | S CD=20060707 |
| CI= | CI | Clinical Relevance | Phrase | S CI=A |
| CR= | CR | References1,3 | Word | S CR=(ELI(W)LILLY) |
| CS= | CS | Corporate Source7 | Word | S CS=(LEIDEN(W)UNIVERSITY) S CS=LEIDEN UNIVERSITY MEDICAL? |
| None | DG | Dose Units, Drug Route, Maximum Dose, Minimun Dose1,2 | ||
| DT= | DT | Document Type8 | Phrase | S DT=BEST EVIDENCE |
| ES= | ES | Adis Score | Phrase | S ES=72 |
| JN= | JN | Journal Name | Phrase | S JN=ANNALS OF THE RHEUMATIC DISEAS? |
| LA= | LA | Language | Phrase | S LA=ENGLISH |
| LK= | LK | R&D Insight Link1,12 | Phrase | S LK=020557 |
| MT= | MT | Meeting Name1 | Word | S MT=(ANNUAL(W)EUROPEAN(S)RHEUMA?) |
| NA= | DG | Drug Name1,2 | Phrase | S NA=METHOTREXATE |
| NG= | NG | Number of Patient Groups4 | Phrase | S NG=7 |
| NP= | NP | Number of Patients1 | Phrase | S NP=110 |
| NS= | NS | Study Name1,13 | Word & Phrase |
S NS=(PROBABLE(W)RA(F) METHOTREXATE) S NS=PROBABLE RA? |
| NT= | NT | Adis Comment | Word | S NT=(ANTIMETABOLITE(W)AGENT) |
| OT= | OT | Outcome5 | Phrase | S OT="METHOTREXATE > PLACEBO" |
| PD= | PD | Publication Date | Phrase | S PD=20060701 |
| PK= | PK | Patient Age Keywords | Phrase | S PK=ADULT |
| None | PM | Patient Minimum Age1 | ||
| PP= | PP | Planned Number of Patients1 | Numeric | S PP=1000 |
| PS= | PS | Study Phase | Phrase | S PS=PHASE III |
| None | PX | Patient Maximum Age1 | ||
| PY= | PY | Publication Year | Phrase | S PY=2006 |
| RH= | RH | Results Highlights5,9 | Word | S RH=(EROSIVE(W)DISEASE) |
| SI= | SI | Study Design | Phrase | S SI=RANDOMISED |
| SK= | SK | Study Endpoints9 | Phrase | S SK=KAPLAN MEIER? |
| SM= | SM | Study Messages5,9 | Word | S SM=(METHOTREXATE(1W)BENEFICIAL) |
| SN= | SN | International Standard Serial Number1 | Phrase | S SN=0003-4967 S SN=00034967 |
| SO= | SO | Source Information10 | Word | S SO=(RHEUMATIC AND JUL(W)2006) |
| ST= | ST | Study Status1 | Phrase | S ST=IN PROGRESS |
| TL= | TL | Clinical Trials Number1,11 | Phrase | S TL=ID01-604 |
| TY= | TY | Study Controls | Phrase | S TY=PLACEBO COMPARISON |
| UD= | None | Update | Phrase | S UD=9999 |
| UP= | UP | Last Update Date1,3 | Phrase | S UP=20060323 |
6 The date that the Adis record was created.
7 The linking between authors and institutions is not present until October 2005.
8 Files 173 & 973 include Best Evidence (beginning 1990), Supporting Evidence (beginning 2005), Ongoing Trials (beginning 2005), and Citation-only records (from 1990-2004). Beginning in 2005, Citation-only records are superseded by Supporting Evidence records. Files 373 & 873 include the former Summary and Citation records only.
9 Available in records from 1996 forward.
10 Search and Display include Journal Name, Volume, Issue, Pages, and Publication Date.
11 MAP RRTL in File 173/973 to find related records.
12 MAP LK in File 107 to find related records.
13 MAP RRNS in File 173/973 to find related records.
| SUFFIX | FIELD NAME | EXAMPLES |
|---|---|---|
| /BEST | Best Evidence Records | S S1/BEST |
| /CIT | Citation-only Records | S ANTIRHEUMATICS/CIT |
| /ONGOING | Ongoing Trials Records | S S3/ONGOING |
| /SUPPORT | Supporting Evidence Records | S UD=?/SUPPORT |
| /YYYY | Publication Year | S S4/2005:2006 |
| SORTABLE FIELDS | EXAMPLES |
|---|---|
| AU, CS, JN, PD, PY, TI | SORT S5/ALL/PY/D SORT S1/ALL/CS |
| RANK FIELDS | EXAMPLES |
|---|---|
| All phrase- and numeric-indexed fields in the Additional Indexes can be ranked. Other RANK codes include: DE | RANK CS RANK AU S4 |
| MAP FIELDS | EXAMPLES |
|---|---|
| LK, RRNS, RRTL | MAP LK TEMP S2 |
| Display codes listed in the Search Options tables can be used to customize output. | TYPE S4/TI, EV, PY/1-5 PRINT S5/TI, AE, AS/ALL |
| NO. |
DIALOGWEB FORMAT |
RECORD CONTENT |
|---|---|---|
| 1 | -- | DIALOG Accession Number |
| 2 | Short | Full Record except Text fields |
| 3 | Medium | Full Record except Text fields |
| 4 | -- | Full Record Tagged |
| 5 | Long | Full Record |
| 6 | Free | Adis Accession Number, Adis Title, Original Title, Creation Date, Publication Date, Last Update Date (for Ongoing Trial records only), Document Type, Record Type, R&D Insight Link, WHO and EphMRA Codes |
| 7 | -- | Full Record except indexing, i.e., /DE,(DI, /DU, /OD, /PR), AC=, CC=, TL= |
| 8 | Free | Adis Accession Number, Adis Title, Original Title, Creation Date, Publication Date, Document Type, Record Type, Last Update Date (for Ongoing Trial records only), Descriptors, WHO and EphMRA codes, R&D Insight Link, Language |
| 9 | Full | Full Record |
| K | -- | KWIC (Key Word In Context) displays a window of text; may be used alone or with other formats |
| FIELD NAME | EXAMPLES | ||
|---|---|---|---|
| If the accession number of a specific record is known, it can be used to display the record directly. | TYPE 016601/9 PRINT 016009/5 |
||
Rates For File: Adis Clinical Trials Insight (1990-present)[173]
Cost per DialUnit: $14.13
Cost per minute: $3.77
Rank Elements $0.07
ALERT (default) $10.00
ALERT (Monthly) $27.00
ALERT (Biweekly/twice a month) * $16.00
ALERT (Weekly) $10.00
ALERT (Daily) * $10.00
ALERT (Calendar weekly) * $10.00
ALERT (Intraday) * $10.00
* = custom scheduled Alerts only
ALERT Number of included prints 0
Format Types Prints
1 $0.00 $0.00
2 $2.00 $2.00
3 $2.00 $2.00
4 $25.00 $25.00
5 $25.00 $25.00
6 $0.00 $0.00
7 $25.00 $25.00
8 $0.00 $0.00
9 $25.00 $25.00
24 $25.00 $25.00
25 $7.00 $7.00
26 $12.00 $12.00
27 $2.00 $2.00
33 $25.00 $25.00
KWIC95 $0.40 NA
KWIC96 $8.00 NA
REDIST/COPY Multiplier Table:
Range Multiplier
1-2 1.00
3-25 1.50
26-100 3.00
101-200 4.00
201-500 6.00
501-1000 8.00
1001 or more 10.00
------------------------------
Supporting Evidence Records:
Formats 4, 5, 7, 9 priced at $ 5.00
UDFs priced at $ 5.00 are: NA, TX, SD, SJ, TR, TL, NS, NP, PK,
SI, TY, PS, SK
Ongoing Trials Records:
Formats 4, 5, 7, 9 priced at $10.00
UDFs priced at $10.00 are: TX, SD, SJ, OC, TL, NS, ST, PK, SI,
TY, PS, SK
Best Evidence Records:
Formats 4, 5, 7, 9 priced at $20.00
UDFs priced at $20.00 are: NA, EV, SM, RH, AE, NT, ES, OT, PU,
CT, SD, SJ, TR, RE, AF, CI, TL, NS, NP, PM, UM, PX, UX, PK, SI,
TY, PS, SK
Rates For File: Adis Clinical Trials Insight (1982-1989)[373]
Cost per DialUnit: $13.70
Cost per minute: $3.52
Format Types Prints
1 $0.00 $0.00
2 $1.50 $1.50
3 $1.50 $1.50
4 $25.00 $25.00
5 $25.00 $25.00
6 $0.00 $0.00
7 $25.00 $25.00
8 $0.00 $0.00
9 $25.00 $25.00
KWIC95 $0.45 NA
KWIC96 $9.00 NA
REDIST/COPY Multiplier Table:
Range Multiplier
1-2 1.00
3-25 1.50
26-100 3.00
101-200 4.00
201-500 6.00
501-1000 8.00
1001 or more 10.00
Rates For File: Adis Clinical Trials Insight (1982 - 1989) - subscribers[873]
Cost per DialUnit: $13.97
Cost per minute: $3.57
Format Types Prints
1 $0.00 $0.00
2 $1.50 $1.50
3 $1.50 $1.50
4 $7.00 $7.00
5 $7.00 $7.00
6 $0.00 $0.00
7 $7.00 $7.00
8 $0.00 $0.00
9 $7.00 $7.00
KWIC95 $0.50 NA
KWIC96 $1.50 NA
Rates For File: Adis Clinical Trials Insight (1990 - present) - subscribers[973]
Cost per DialUnit: $13.70
Cost per minute: $3.52
Rank Elements $0.07
ALERT (default) $10.25
ALERT (Monthly) $27.00
ALERT (Biweekly/twice a month) * $23.00
ALERT (Weekly) $10.25
ALERT (Daily) * $10.25
ALERT (Calendar weekly) * $10.25
ALERT (Intraday) * $10.25
* = custom scheduled Alerts only
ALERT Number of included prints 0
Format Types Prints
1 $0.00 $0.00
2 $2.00 $2.00
3 $2.00 $2.00
4 $7.00 $7.00
5 $7.00 $7.00
6 $0.00 $0.00
7 $7.00 $7.00
8 $0.00 $0.00
9 $7.00 $7.00
24 $7.00 $7.00
25 $3.50 $3.50
26 $7.00 $7.00
27 $2.00 $2.00
33 $7.00 $7.00
KWIC95 $0.45 NA
KWIC96 $1.50 NA
