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Completed

NCT Number: NCT01023256

Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis

GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

MorphoSys Investigative sites, MorphoSys Investigative Sites, Bulgaria

Loading trial locations.

About this study

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects 0.5% to 1% of the adult population world wide. RA primarily affects the joints and is characterized by chronic inflammation of the synovial tissue, which eventually leads to the destruction of cartilage, bone and ligaments and can cause joint deformity.

Pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6 and granulocyte macrophage colony stimulating factor (GM-CSF), which lead to the activation and proliferation of immune cells, are found to be increased in the inflamed joint. Several preclinical findings support an anti-GM-CSF therapy for RA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rheumatoid arthritis (RA) per revised 1987 ACR criteria
  • Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint
  • CRP > 5.0 mg/L (RF and anti-CCP seronegative); CRP >2 mg/l (RF and/or anti-CCP seropositive)
  • DAS28 ≤ 5.1
  • Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).
  • Negative PPD tuberculin skin test

Exclusion criteria

  • Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
  • Any history of ongoing, significant or recurring infections
  • Any active inflammatory diseases other than RA
  • Treatment with a systemic investigational drug within 6 months prior to screening
  • Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
  • Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
  • Hepatic or renal insufficiency

Treatment and study plan

MOR103

Drug

MOR103 0.3 mg/kg or placebo iv x 4 doses

Primary outcomes

  1. Percentages of Patients With Treatment-emergent or Serious Adverse Events

    Time frame: From the first dose through the 16-week visit

    Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of >5 % (>1 patient) in any treatment group, please see the adverse events listing.

Secondary outcomes

  1. Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks

    Time frame: Change from baseline to week 4 (1 week after last MOR103 dose)

    The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).

  2. Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks

    Time frame: Change from baseline to week 8 (5 weeks after last MOR103 dose)

    The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity)

  3. Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4

    Time frame: Week 4 (1 week after last MOR103 dose)

    The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.

  4. Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8

    Time frame: Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8

    Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.

  5. Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8

    Time frame: Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8

    Patient-reported outcomes included patient's self-assessment of pain (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best).

Other outcomes

  1. Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4

    Time frame: Change from screening to week 4 (1 week after last MOR103 dose)

    Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.

  2. Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8

    Time frame: Change from screening to week 8

    Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.

Sponsors and collaborators

Lead sponsor

MorphoSys AG

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of MOR103 Administered Intravenously to Patients With Active Rheumatoid Arthritis

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2009
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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