- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00132769
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
29 luglio 2015 aggiornato da: Merck Sharp & Dohme LLC
A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis
This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
106
Fase
- Fase 2
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications
- Other criteria also apply
Exclusion Criteria:
- Other major illnesses
- Past history of certain other disorders
- Certain prohibited medications
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: MK-0873
MK-0873 1.25 mg twice daily for 12 weeks
|
MK-0873 1.25 mg twice daily for 12 weeks
|
Comparatore placebo: Placebo
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
|
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Swollen Joint Count
Lasso di tempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics.
The total number of joints graded 1, 2, or 3 were then counted to yield the SJC.
SJC ranged from 1-66, with increasing score indicating greater number of swollen joints.
SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean.
Change from Baseline = Treatment Period Mean SJC - Baseline SJC.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants With American College of Rheumatology 20% Response [ACR20]
Lasso di tempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]).
The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Change From Baseline in Tender Joint Count
Lasso di tempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws.
The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC.
TJC ranges from 1-68, with increasing score indicating greater number of tender joints.
TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean.
Change from Baseline = Treatment Period Mean TJC - Baseline TJC.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Patient Global Assessment of Disease Activity
Lasso di tempo: The average of Treatment Weeks 8, 10 and 12
|
At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: "Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing."
The VAS ranges from "Very Well" (0) to "Very Poor" (100).
The mean score at Treatment Weeks 8, 10 and 12 was calculated.
A lower score indicates a better disease activity.
|
The average of Treatment Weeks 8, 10 and 12
|
Investigator Global Assessment of Disease Activity
Lasso di tempo: Treatment Week 12
|
At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5).
A lower score indicates a more positive assessment of participant disease activity.
|
Treatment Week 12
|
Patient Global Assessment of Response to Therapy
Lasso di tempo: Treatment Week 12
|
Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4).
A higher score indicates a more positive response to study drug.
|
Treatment Week 12
|
Health Assessment Questionnaire Disability Index
Lasso di tempo: The average of Treatment Weeks 8, 10 and 12
|
The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.
Responses range from 0=No disability to 3=Completely disabled.
The score for each category subscale is the single response within the category with the highest score (greatest difficulty).
The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.
|
The average of Treatment Weeks 8, 10 and 12
|
Patient's Assessment of Pain
Lasso di tempo: Treatment Week 12
|
At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from "No pain" (0) to "Extreme pain" (100).
A lower score indicates less pain.
|
Treatment Week 12
|
Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein
Lasso di tempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
C-reactive protein levels rise in response to inflammation in the body.
The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect.
On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12.
A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2005
Completamento primario (Effettivo)
1 novembre 2005
Completamento dello studio (Effettivo)
1 novembre 2005
Date di iscrizione allo studio
Primo inviato
2 agosto 2005
Primo inviato che soddisfa i criteri di controllo qualità
19 agosto 2005
Primo Inserito (Stima)
22 agosto 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
30 luglio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 luglio 2015
Ultimo verificato
1 luglio 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie del tessuto connettivo
- Artrite
- Artrite, reumatoide
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Inibitori della fosfodiesterasi
- Inibitori della fosfodiesterasi 4
- MK 0873
Altri numeri di identificazione dello studio
- 0873-012
- 2005_029 (Altro identificatore: Telerex Study Number)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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