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A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

8. desember 2019 oppdatert av: SinoMab BioScience Ltd

A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase II Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severe Active Rheumatoid Arthritis Receiving Methotrexate

This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

156

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
      • Beijing, Kina, 100032
        • Peking Union Medical College Hostipal

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Adult patients 18-75 years of age.
  • Rheumatoid arthritis (RA) for ≥ 12 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
  • Moderate to severe active RA with swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
  • At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes
  • Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.

Exclusion Criteria:

  • Rheumatic autoimmune disease other than RA.
  • Use of any biological DMARDs for RA within past 6 months.
  • Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
  • Active infection, or history of serious or chronic infection

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SM03 600 mg*2
SM03: 600 mg intravenous (IV) on week 0,2, and week 12,14; placebo: 600 mg intravenous (IV) on week 4 and16; Methotrexate: 7.5-20 mg/wk oral.
Legemiddel: SM03
SM03: 600 mg intravenøst ​​(IV)
Legemiddel: Placebo
Placebo: 600 mg intravenøst ​​(IV)
Legemiddel: Methotrexate
methotrexate: 7.5-20 mg/week oral
Eksperimentell: SM03 600 mg*3
SM03: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.
Legemiddel: SM03
SM03: 600 mg intravenøst ​​(IV)
Legemiddel: Methotrexate
methotrexate: 7.5-20 mg/week oral
Placebo komparator: placebo*3
placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.
Legemiddel: Placebo
Placebo: 600 mg intravenøst ​​(IV)
Legemiddel: Methotrexate
methotrexate: 7.5-20 mg/week oral

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
Tidsramme: Week 24

To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:

  • Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]);
  • Patient's global assessment of disease activity (assessed using a 10 cm VAS);
  • Patient's assessment of pain (assessed using a 10 cm VAS);
  • Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
  • Acute phase reactant: C-reactive protein (CRP)
Week 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 4,8,12, 16
Tidsramme: Week 4,8,12,16

To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:

  • Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]);
  • Patient's global assessment of disease activity (assessed using a 10 cm VAS);
  • Patient's assessment of pain (assessed using a 10 cm VAS);
  • Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
  • Acute phase reactant: C-reactive protein (CRP)
Week 4,8,12,16
Percentage of Participants With an ACR50 Response at Week 24
Tidsramme: Week 24

To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:

  • Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]);
  • Patient's global assessment of disease activity (assessed using a 10 cm VAS);
  • Patient's assessment of pain (assessed using a 10 cm VAS);
  • Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
  • Acute phase reactant: C-reactive protein (CRP)
Week 24
Percentage of Participants With an ACR70 Response at Week 24
Tidsramme: Week 24

To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:

  • Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale [VAS]);
  • Patient's global assessment of disease activity (assessed using a 10 cm VAS);
  • Patient's assessment of pain (assessed using a 10 cm VAS);
  • Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);
  • Acute phase reactant: C-reactive protein (CRP)
Week 24
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24
Tidsramme: Baseline and Week 24

The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:

  • The number of swollen and tender joints assessed using the 28-joint count;
  • Erythrocyte sedimentation rate (ESR);
  • Patient's global assessment of disease activity measured on a 10 cm visual analog scale.

The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Baseline and Week 24
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24
Tidsramme: Week 24

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.

A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.

A Moderate Response is defined as either:

an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.

No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1.
Week 24
Percentage of Participants With Adverse Events
Tidsramme: Week 0 to 24
Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.
Week 0 to 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SinoMab BioScience Ltd

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. desember 2014

Primær fullføring (Faktiske)

3. februar 2016

Studiet fullført (Faktiske)

3. februar 2016

Datoer for studieregistrering

Først innsendt

5. desember 2019

Først innsendt som oppfylte QC-kriteriene

8. desember 2019

Først lagt ut (Faktiske)

10. desember 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. desember 2019

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SM03-RA-II-V3.3

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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