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Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)

18. März 2019 aktualisiert von: Merck Sharp & Dohme LLC

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy. The primary hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as measured by the percentage of participants who achieve American College of Rheumatology 20 (ACR 20) response after 12 weeks of treatment.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

In Base Study Phase IIa, participants were to receive blinded MK-8457 100 mg or matched placebo for up to 24 weeks. At Week 12 and 18 of Phase IIa, efficacy evaluation was conducted to assess eligibility for early escape, defined as <20% reduction in both tender and swollen joint counts. The study plan included Base Study Phase IIb in which dose range finding or dose-response was to be evaluated, depending on the outcome of Phase IIa. Participants who completed Phase IIa or Phase IIb and those eligible for early escape could enroll in Period 3, a 2-year Safety Extension.

All participants must have been treated with MTX for at least 3 months prior to screening and have been receiving a stable dose of MTX for at least 4 weeks prior to screening.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

82

Phase

  • Phase 2

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis for at least 6 months prior to screening
  • Active rheumatoid arthritis as defined by the presence of >= 6 swollen joints (of 66 count) and >= 6 tender joints (of 68 joint count)
  • C-reactive protein blood level >0.9 mg/dL
  • Anti-citrullinated protein antibody positive and/or rheumatoid factor positive at screening
  • American College of Rheumatology Functional Class I, II, or III
  • Received methotrexate for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening
  • If using oral corticosteroids, the participant must be on a stable dose of 10 mg prednisone
  • No history of either untreated, latent, or active tuberculosis prior to baseline
  • Participants of reproductive potential must agree to remain abstinent or use 2 acceptable methods of birth control

Exclusion Criteria:

  • Presence of inflammatory disease other than rheumatoid arthritis, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
  • Positive hepatitis B surface antigen or hepatitis C test result or the presence of Human immunodeficiency virus (HIV) infection
  • HIV positive
  • User of recreational or illicit drugs or has had a history (within the previous 2 years) of drug or alcohol abuse or dependence
  • Females of childbearing potential who are pregnant, intend to become pregnant, or are lactating;
  • Severe opportunistic infection within 6 months prior to study start.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Base Study Phase IIa: MK-8457
Participants received MK-8457 100 mg dosed twice daily (BID) orally with MTX at the stable dose received upon study enrollment. Phase IIa lasted up to 24 weeks.
Arzneimittel: MK-8457 100 mg
MK-8457 100 mg oral dosiert BID
Arzneimittel: Methotrexate
MTX dosed at the stable dose receive upon study entry
Andere Namen:
  • MTX
Placebo-Komparator: Base Study Phase IIa: Placebo
Participants received placebo dosed BID orally with MTX at the stable dose received upon study enrollment. Phase IIa lasted up to 24 weeks.
Arzneimittel: Methotrexate
MTX dosed at the stable dose receive upon study entry
Andere Namen:
  • MTX
Arzneimittel: Dose-Matched Placebo
Dose-matched placebo dosed orally BID
Experimental: Safety Extension Period 3: MK-8457
Participants received MK-8457 100 mg BID orally with MTX at the stable dose received upon study enrollment. Period 3 was to last up to 2 years.
Arzneimittel: MK-8457 100 mg
MK-8457 100 mg oral dosiert BID
Arzneimittel: Methotrexate
MTX dosed at the stable dose receive upon study entry
Andere Namen:
  • MTX

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Prozentsatz der Teilnehmer, die in Woche 12 eine Antwort von 20 des American College of Rheumatology (ACR) erreichten
Zeitfenster: Woche 12
ACR-Antworten sind numerische Messungen der Verbesserung mehrerer Krankheitsbewertungskriterien. Eine ACR20-Reaktion ist definiert als eine Verbesserung von ≥20 % in 1) der Anzahl geschwollener Gelenke (66 Gelenke) und der Anzahl empfindlicher Gelenke (68 Gelenke) (0 = nicht vorhanden; 1 = vorhanden) und 2) einer Verbesserung von ≥ 20 % in drei der folgenden Bereiche 5 Bewertungen: a) Gesamtbeurteilung der Schmerzen eines Teilnehmers auf einer visuellen Analogskala (VAS, kein Schmerz = 0 bis extremer Schmerz = 100); b) Gesamtbewertung der Krankheitsaktivität des Patienten VAS (sehr gut = 0 bis sehr schlecht = 100); c) Investigator's Global Assessment of Disease Activity VAS (sehr gut = 0 bis sehr schlecht = 100; d) Beurteilung der Funktion durch den Teilnehmer in 8 Funktionsbereichen, gemessen anhand des Health Assessment Questionnaire (HAQ), Gesamtpunktzahl reicht von „kein Schwierigkeitsgrad“ = 0 zur Unfähigkeit, Aufgaben auszuführen =24; und e) Serum-C-reaktives Protein (Abnahme zeigt Verbesserung an). Diese Ergebnismessung galt nur für Teilnehmer der Basisstudie.
Woche 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Disease Activity Score (DAS28) as Measured by Erythrocyte Sedimentation Rate (ESR) at Week 12
Zeitfenster: Baseline and Week 12
The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater rheumatoid arthritis (RA) disease activity. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in DAS28 as Measured by C-Reactive Protein (CRP) at Week 12
Zeitfenster: Baseline and Week 12
The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Percentage of Participants Achieving an ACR70 Response at Week 12
Zeitfenster: Week 12
ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR70 response is defined as a ≥70% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥70% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.
Week 12
Percentage of Participants Achieving Hybrid ACR Response at Week 12
Zeitfenster: Week 12
Hybrid ACR Response evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a categorical score of the mean change in the core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP). The mean percentage improvement from Baseline in the core set measures was computed and used with the participant's ACR20, ACR50, and ACR70 status to determine the hybrid ACR response in a lookup table. The range of values was -100 to 100, with a positive change indicating improvement. This outcome measure applied to Base Study participants only.
Week 12
Percentage of Participants Achieving an ACR-N Response at Week 12
Zeitfenster: Week 12
The ACR-N response is the minimum of the following: 1) the percent decrease from Baseline in tender joint counts (68 joints, 0 = absent, 1 = present); 2) the percent decrease from Baseline in swollen joint counts (66 joints, 0 = absent, 1 = present); and 3) the median percent decrease from Baseline for the following: a) Patient's Global Assessment of Pain (VAS, 0 mm = "no pain" and 100 mm = "extreme pain"); b) Patient's Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); c) Investigator's Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); d. physical function as measured by the HAQ (Likert scale, 0 to 3 with a lower score indicating less disability); and e) CRP. This outcome measure applied to Base Study participants only.
Week 12
Percentage of Participants Achieving a DAS28-ESR Response at Week 12
Zeitfenster: Week 12
The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-ESR value for a given visit, change in DAS28-ESR is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-ESR was reported. This outcome measure applied to Base Study participants only.
Week 12
Percentage of Participants Achieving a DAS28-CRP Response at Week 12
Zeitfenster: Week 12
The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-CRP value for a given visit, change in DAS28-CRP is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-CRP was reported. This outcome measure applied to Base Study participants only.
Week 12
Percentage of Participants Achieving DAS28-ESR Remission at Week 12
Zeitfenster: Week 12
The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-ESR remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.
Week 12
Percentage of Participants Achieving DAS28-CRP Remission at Week 12
Zeitfenster: Week 12
The DAS28-CRP is a continuous parameter derived from the formula: 0.56 × the square root of the tender joint count (0-28) + 0.28 × the square root of the swelling joint count (0-28) + 0.36 × the C reactive protein value (in mg/L +1) + 0.014 × Patient's Global Assessment of Disease Activity VAS of 0-100 mm + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-CRP remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.
Week 12
DAS28-ESR Area Under the Curve (AUC)
Zeitfenster: Up to 12 weeks
DAS28-ESR AUC was to be calculated from the DAS28-ESR score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-ESR AUC was to be calculated using the trapezoidal rule as the DAS28-ESR multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.
Up to 12 weeks
DAS28-CRP Area Under the Curve (AUC)
Zeitfenster: Up to 12 weeks
DAS28-CRP AUC was to be calculated from the DAS28-CRP score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-CRP AUC was to be calculated using the trapezoidal rule as the DAS28-CRP multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.
Up to 12 weeks
Change From Baseline in Tender Joint Count at Week 12
Zeitfenster: Baseline and Week 12
Tender Joint Count was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in Swollen Joint Count at Week 12
Zeitfenster: Baseline and Week 12
Swollen joint count included 66 joints (same joints as for tender joint count except this excluded evaluation of hips) that were assessed for the presence of swelling. Soft tissue swelling was considered to be present if there was palpable or visible evidence of capsular distention considered to be due to either synovial thickening and/or a joint effusion. Bony swelling, nodule formation, and joint deformity were excluded from consideration. A swollen joint was scored as 0 = Absent; 1 = Present for each joint. The overall swollen joint count ranged from 0 to 66. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12
Zeitfenster: Baseline and Week 12
SDAI is the simple linear sum of the following parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, Patient's Global Assessment of Disease Activity [PGA, VAS 0 to 10 cm], Investigator's Global Assessment of Disease Activity (MDGA, VAS 0 to 10 cm) and CRP levels (mg/dL). SDAI =TJC + SJC + PGA + MDGA + CRP. Overall scores can range from 0.0 to 86.0. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in the Short Form Health Survey (SF-36) at Week 12
Zeitfenster: Baseline and Week 12
The SF-36 is a health-related quality of life instrument that consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. The lower the score the greater the disability i.e., a score of 0 corresponds to maximum disability and a score of 100 corresponds to no disability. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12
Zeitfenster: Baseline and Week 12
The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). The higher the participant's response to the questions the greater the participant's fatigue. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in the Patient's Global Assessment of Disease Status/Activity (PGADSA) at Week 12
Zeitfenster: Baseline and Week 12
A participant's overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS, where 0 mm = doing very well to 100 mm = doing very poor. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in the Investigator's Global Assessment of Disease Status/Activity (IGADSA) at Week 12
Zeitfenster: Baseline and Week 12
The Investigator's Global Assessment of Disease Status/Activity (IGADSA) is measured with scores ranging from 0 to 100 mm (VAS, 0 mm = doing very well to 100 mm = doing very poor). A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in the Patient's Global Assessment of Pain (PGAP) at Week 12
Zeitfenster: Baseline and Week 12
A participant's overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS where 0 mm = "no pain" and 100 mm = "extreme pain". A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Änderung gegenüber dem Ausgangswert im Health Assessment Questionnaire Disability (HAQ Disability Index) in Woche 12
Zeitfenster: Ausgangswert und Woche 12
Der Funktionsstatus des Teilnehmers wurde anhand des Disability Index des HAQ auf einer Likert-Skala beurteilt. Dieses aus 20 Fragen bestehende Instrument bewertet den Schwierigkeitsgrad einer Person bei der Erfüllung von Aufgaben in 8 Funktionsbereichen (Anziehen, Aufstehen, Essen, Gehen, Hygiene, Greifen, Greifen und Aktivitäten des täglichen Lebens). Die Antworten in jedem Funktionsbereich werden von 0 (keine Schwierigkeit) bis 3 (Unfähigkeit, eine Aufgabe in diesem Bereich auszuführen) bewertet. Der Gesamtwert für den Behinderungsindex ist der Mittelwert der 8 Funktionsbereichswerte und liegt ebenfalls zwischen 0 und 3, wobei ein niedrigerer Wert auf eine geringere Behinderung hinweist. Eine negative Veränderung gegenüber dem Ausgangswert weist auf eine Verbesserung hin. Diese Ergebnismessung galt nur für Teilnehmer der Basisstudie.
Ausgangswert und Woche 12
Change From Baseline in Serum C-Reactive Protein (CRP) at Week 12
Zeitfenster: Baseline and Week 12
C-Reactive Protein is an inflammatory marker with a normal reference range of less than 0.9 mg/dL. Change from Baseline in CRP at Week 12 (Week 12 concentration minus Baseline concentration). This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
Zeitfenster: Baseline and Week 12
The ESR is the rate at which red blood cells sediment in a period of one hour, and is a non-specific measure of inflammation. Change from Baseline is ESR at Week 12 minus ESR at Baseline. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Change From Baseline in Hemoglobin at Week 12
Zeitfenster: Baseline and Week 12
Hemoglobin is the iron-containing oxygen-transport metalloprotein in red blood cells. Change from Baseline is hemoglobin at Week 12 minus hemoglobin at Baseline. This outcome measure applied to Base Study participants only.
Baseline and Week 12
Prozentsatz der Teilnehmer, die in Woche 12 eine ACR50-Antwort erreichten
Zeitfenster: Woche 12
ACR-Antworten sind numerische Messungen der Verbesserung mehrerer Krankheitsbewertungskriterien. Eine ACR50-Reaktion ist definiert als eine Verbesserung um ≥ 50 % in 1) der Anzahl geschwollener Gelenke (66 Gelenke) und der Anzahl empfindlicher Gelenke (68 Gelenke) (0 = nicht vorhanden; 1 = vorhanden) und 2) Verbesserung von ≥ 50 % in drei der folgenden Bereiche 5 Bewertungen: a) Gesamtbeurteilung der Schmerzen eines Teilnehmers auf einer visuellen Analogskala (VAS, kein Schmerz = 0 bis extremer Schmerz = 100); b) Gesamtbewertung der Krankheitsaktivität des Patienten VAS (sehr gut = 0 bis sehr schlecht = 100); c) Investigator's Global Assessment of Disease Activity VAS (sehr gut = 0 bis sehr schlecht = 100; d) Beurteilung der Funktion durch den Teilnehmer in 8 Funktionsbereichen, gemessen anhand des Health Assessment Questionnaire (HAQ), Gesamtpunktzahl reicht von „kein Schwierigkeitsgrad“ = 0 zur Unfähigkeit, Aufgaben auszuführen =24; und e) Serum-C-reaktives Protein (Abnahme zeigt Verbesserung an). Diese Ergebnismessung galt nur für Teilnehmer der Basisstudie.
Woche 12
Percentage of Participants With an ACR20 Response Over Time
Zeitfenster: Week 1, Week 2, Week 4, Week 6, Week 18 and Week 24
ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.
Week 1, Week 2, Week 4, Week 6, Week 18 and Week 24

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Merck Sharp & Dohme LLC

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Mai 2012

Primärer Abschluss (Tatsächlich)

3. Oktober 2013

Studienabschluss (Tatsächlich)

3. Oktober 2013

Studienanmeldedaten

Zuerst eingereicht

30. März 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. März 2012

Zuerst gepostet (Schätzen)

2. April 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. März 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. März 2019

Zuletzt verifiziert

1. März 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • P08683 (Andere Kennung: Merck)
  • MK-8457-008 (Andere Kennung: Merck)
  • 2012-000439-17 (EudraCT-Nummer)
  • 132235 (Registrierungskennung: JAPIC-CTI)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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