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: April 9, 2014
Last verified: April 2014
  Purpose

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


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 4208
Study Start Date: April 2004
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077258

  Show 303 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01077258     History of Changes
Other Study ID Numbers: P10-448
Study First Received: February 25, 2010
Results First Received: February 28, 2014
Last Updated: April 9, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Safety
Long-term observation
Routine Clinical Setting
Rheumatoid Arthritis
Effectiveness

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014