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Maraviroc in Rheumatoid Arthritis

30. oktober 2014 oppdatert av: Pfizer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.

Studietype

Intervensjonell

Registrering (Faktiske)

128

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Australia
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Pfizer Investigational Site
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Pfizer Investigational Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7001
        • Pfizer Investigational Site
  • Forente stater
    • California
      • Huntington Beach, California, Forente stater, 92646
        • Pfizer Investigational Site
      • San Francisco, California, Forente stater, 94115
        • Pfizer Investigational Site
    • Connecticut
      • Hamden, Connecticut, Forente stater, 06518
        • Pfizer Investigational Site
      • Meriden, Connecticut, Forente stater, 06450
        • Pfizer Investigational Site
      • New Haven, Connecticut, Forente stater, 06511-5473
        • Pfizer Investigational Site
      • New Haven, Connecticut, Forente stater, 06510-2716
        • Pfizer Investigational Site
    • Florida
      • Daytona Beach, Florida, Forente stater, 32114
        • Pfizer Investigational Site
      • Port Orange, Florida, Forente stater, 32127
        • Pfizer Investigational Site
    • Georgia
      • Savannah, Georgia, Forente stater, 31405
        • Pfizer Investigational Site
      • Savannah, Georgia, Forente stater, 31406
        • Pfizer Investigational Site
    • Illinois
      • Moline, Illinois, Forente stater, 61265
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, Forente stater, 42431
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, Forente stater, 49007
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, Forente stater, 49048
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68154
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
        • Pfizer Investigational Site
    • New York
      • Syracuse, New York, Forente stater, 13210
        • Pfizer Investigational Site
    • North Carolina
      • Hickory, North Carolina, Forente stater, 28601
        • Pfizer Investigational Site
      • Hickory, North Carolina, Forente stater, 28602
        • Pfizer Investigational Site
    • North Dakota
      • Minot, North Dakota, Forente stater, 58701
        • Pfizer Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Forente stater, 16635
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 082
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
      • Bangalore, Karnataka, India, 560003
        • Pfizer Investigational Site
  • Italia
      • Genova, Italia, 16132
        • Pfizer Investigational Site
      • Pavia, Italia, 27100
        • Pfizer Investigational Site
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Pfizer Investigational Site
      • Guadalajara, Jalisco, Mexico, CP 44340
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1600-035
        • Pfizer Investigational Site
      • Lisbon, Portugal, 1000-247
        • Pfizer Investigational Site
  • Spania
      • Barcelona, Spania, 08035
        • Pfizer Investigational Site
      • Madrid, Spania, 28007
        • Pfizer Investigational Site
      • Sevilla, Spania, 41014
        • Pfizer Investigational Site
    • A Coruña
      • Santiago de Compostela, A Coruña, Spania, 15705
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 10117
        • Pfizer Investigational Site
      • Berlin, Tyskland, 14059
        • Pfizer Investigational Site
      • Leipzig, Tyskland, 04103
        • Pfizer Investigational Site
  • Ukraina
      • Dnipropetrovsk, Ukraina, 49005
        • Pfizer Investigational Site
      • Kharkiv, Ukraina, 61000
        • Pfizer Investigational Site
      • Simferopol, Ukraina, 95017
        • Pfizer Investigational Site

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Must be legal age of consent
  • Must have active rheumatoid arthritis based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria); minimum disease criteria required for entry into the efficacy component of the study
  • Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III
  • Must be receiving methotrexate for at least 12 weeks duration and on a stable dose for 4 weeks.

Exclusion Criteria:

  • Diagnosed with any other inflammatory arthritis or a secondary non-inflammatory arthritis that would interfere with disease activity assessments.
  • Subject receiving prior treatment with certain medications for rheumatoid arthritis
  • Tuberculosis and/or a positive tuberculin reaction
  • Significant trauma or major surgery within 2 months
  • History of alcohol and/or drug abuse outside of a defined period of abstinence
  • History of or a finding at screening of postural hypotension
  • Any condition that would affect the oral absorption of the drug
  • History of cancer and in remission less than 3 years or Grade III-IV congestive heart failure
  • Having an infection of human immunodeficiency virus (HIV), Hepatitis B or C or evidence of any active infection
  • Abnormalities of clinical or laboratory assessments completed at the screening visit such as elevated liver enzymes, decreased hemoglobin or an abnormal ECG
  • Having a positive chemokine receptor 5 (CCR5) delta 32 mutation
  • Requiring the use of certain medications
  • Lactating or pregnant women or subjects have reproductive potential unwilling to use an adequate method of birth control
  • Chronic or recent serious or life-threatening infection; severe , progressive and/or uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease within 12 weeks of the first dose.

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 2
Legemiddel: Maraviroc Placebo
Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
Eksperimentell: 1
This study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks.
Legemiddel: Maraviroc
300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
American College of Rheumatology (ACR) 20% Responders at Week 12
Tidsramme: Week 12
A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain (Visual Analogue Scale [VAS]), Patient's Global Assessment of Arthritis (VAS), Physician's Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-Reactive Protein (CRP).
Week 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ACR 20% Responders at Weeks 1, 2, 4, and 8
Tidsramme: Weeks 1, 2, 4, and 8
A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 20% data were collected, but not analyzed.
Weeks 1, 2, 4, and 8
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Tidsramme: Weeks 1, 2, 4, 8, and 12
A subject was an ACR 50 responder if: the counts for both tender and swollen joints had reduced by 50% or more from baseline; and 3 out of the following 5 assessments showed reduction of 50% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 50% data were collected, but not analyzed.
Weeks 1, 2, 4, 8, and 12
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Tidsramme: Weeks 1, 2, 4, 8, and 12
A subject was an ACR 70 responder if: the counts for both tender and swollen joints had reduced by 70% or more from baseline; and 3 out of the following 5 assessments showed reduction of 70% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 70% data were collected, but not analyzed.
Weeks 1, 2, 4, 8, and 12
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12
Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender/painful joint count data were collected, but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12
Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data were collected, but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12
The severity of arthritis was scored by the subject between 0 (no pain) and 100 (most severe pain) on a 100 mm VAS. Change from baseline at each visit was analyzed for Patient's Assessment of Arthritis Pain. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Assessment of Arthritis Pain data were collected, but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12
Subjects answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Subjects responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. Change from baseline at each visit was analyzed for Patient's Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Global Assessment of Arthritis Pain data were collected, but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12
Physician's evaluation based on subject's disease signs, functional capacity and physical exam. Response recorded using 5-point scale: 1=Very Good, 2=Good, 3=Fair, 4=Poor and 5=Very Poor. Change from baseline at each visit was analyzed for Physician's Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy thus Week 16 Physician's Global Assessment of Arthritis Pain data were collected but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12
HAQ-DI assesses degree of difficulty experienced in daily activity categories (dressing/grooming, arising, eating, walking, hygiene, reach, grip and other activities) over the past week. There are 20 questions and difficulty is scored from 0 (none), 1 (some), 2 (much) and 3 (unable to do). Scores were then averaged to give the disability index (scale of 0 to 3). Change from baseline at each visit was analyzed. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 HAQ-DI data were collected but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12
Change from baseline at each visit were analyzed for CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 CRP data were collected, but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
Tidsramme: Baseline, Weeks 1, 2, 4, 8, and 12

DAS28-4 (CRP) was calculated using the following formula:

DAS28- 4(CRP) = 0.56 √28 Tender Joint Count + 0.28 √28 Swollen Joint Count + 0.36*natural logarithm(CRP + 1) + 0.014*Patient Global Assessment + 0.96. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at each visit was analyzed for DAS28-4 (CRP). The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 DAS28-4 (CRP) data were collected, but not analyzed.
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Mean Orthostatic Blood Pressure (BP)
Tidsramme: Baseline, 16 weeks
Supine BP was recorded after 5 minutes lying down; subjects then sat for 2 minutes then stood for 2 minutes and standing BP was recorded. Orthostatic BP = either a systolic BP drop > 20 mmHg, or diastolic BP drop > 10 mmHg and/or drop in systolic BP < 90 mmHg. If a subject met the orthostatic criteria, they were required to complete 2 additional readings to provide a triplicate reading. The means of replicate BP values were used in the analysis. Baseline = the latest non-missing value from a range of pre-treatment visits. Change from baseline to Week 16 was analyzed for orthostatic BP.
Baseline, 16 weeks
Change From Baseline in Mean Heart Rate
Tidsramme: Baseline, 16 weeks
Heart rate = standing and supine at the same time the orthostatic BP measurements were obtained. Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were not used.
Baseline, 16 weeks
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
Tidsramme: Baseline, 16 weeks
Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Maximum increase from baseline in supine and standing systolic BP was > = 30 mmHg, and maximum increase from baseline in supine and standing diastolic BP was > = 20 mmHg.
Baseline, 16 weeks
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
Tidsramme: Baseline, 16 weeks
Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used. QTc interval was not measured for the PK populations.
Baseline, 16 weeks
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).
Tidsramme: Baseline, 16 weeks
Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.
Baseline, 16 weeks
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Tidsramme: Baseline, 16 weeks
Maximum QTcB, QTcF, and QTc intervals were defined as 450 to < 480 msec, 480 to < 500 msec, or > = 500 msec.
Baseline, 16 weeks
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12
Tidsramme: Baseline, Weeks 4 and 12
The SF-36 v.2 (Acute version) is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (physical component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.
Baseline, Weeks 4 and 12
Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12
Tidsramme: Baseline, Weeks 4 and 12
The SF-36 v.2 (Acute version) [12] is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (mental component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.
Baseline, Weeks 4 and 12
Number of Subjects With Withdrawal From Study Due to Lack of Efficacy
Tidsramme: 16 weeks
Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator's judgement.
16 weeks
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
Tidsramme: Weeks 1 to 12
Withdrawal due to lack of efficacy was collected based on the investigator's judgement. Time to withdrawal was measured by the probability that a subject did not withdraw due to lack of efficacy by a particular visit. This was a statistical estimate (Kaplan-Meier Survival Analysis) of the probability that a participant would not withdraw due to lack of efficacy.
Weeks 1 to 12
Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1
Tidsramme: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Effect of maraviroc on the PK of MTX (comparison of AUC0-4 of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1
Tidsramme: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Effect of maraviroc on the PK of MTX (comparison of Cmax of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1
Tidsramme: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)

Samarbeidspartnere og etterforskere

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

Sponsor

Pfizer

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.

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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

1. februar 2007

Primær fullføring (Faktiske)

1. oktober 2008

Studiet fullført (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først innsendt

25. januar 2007

Først innsendt som oppfylte QC-kriteriene

25. januar 2007

Først lagt ut (Anslag)

29. januar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. november 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2014

Sist bekreftet

1. oktober 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A4001056

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