Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077258
First received: February 25, 2010
Last updated: February 28, 2014
Last verified: February 2014

February 25, 2010
February 28, 2014
April 2004
February 2013   (final data collection date for primary outcome measure)
  • Change From Baseline in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
  • Percentage of Participants in DAS28 Remission [ Time Frame: Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Effectiveness: DAS28 (Disease Activity Score), clinical remission. Safety: side effects [ Time Frame: Month 0, 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01077258 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With a Significant Therapeutic Response [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]

    Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.

    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

  • Percentage of Participants With Low, Moderate and High Disease Activity [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]

    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.

    Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.

  • Erythrocyte Sedimentation Rate (ESR) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
  • C-Reactive Protein (CRP) Levels Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.
  • Tender Joint Count (TJC) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
  • Swollen Joint Count (SJC) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
  • Hannover Functional Questionnaire (FFbH) Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]

    A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula:

    FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.

  • Patients Global Assessment of Disease Activity Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18 and 24 ] [ Designated as safety issue: No ]
    Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
  • Participants Assessment of Fatigue Over Time [ Time Frame: Baseline and Month 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
  • Participants Assessment of Pain Over Time [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
  • Percentage of Participants With Impairment in Daily Activities [ Time Frame: Baseline and Months 3, 6, 9, 18, and 24 ] [ Designated as safety issue: No ]
    Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.
  • Number of Days Missed From Work Due to Rheumatoid Arthritis [ Time Frame: Baseline and Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.
  • Percentage of Participants With In-patient Hospitalization [ Time Frame: Month 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.
  • Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication [ Time Frame: Baseline and Months 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
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Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.

Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Community sample: patients with rheumatoid arthritis who resided in Germany. German regulations state that all patients are eligible for non-interventional studies; there are no exclusions. Adult patients (≥ 18 years of age) with RA who were preparing to initiate adalimumab therapy according to the product label were eligible for study enrollment. The eligibility criteria below reflect the approved label as stated in the German Summary of Product Characteristics (SPC) for Humira.

Rheumatoid Arthritis
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Rheumatoid arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4208
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate
  • Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. In case of incompatibility with methotrexate, Humira can be used as monotherapy

Exclusion Criteria:

  • Hypersensitivity against the drug or one of the other ingredients
  • Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
  • Moderate to severe cardiac insufficiency
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01077258
P10-448
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
AbbVie
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP